IEC Ref. No.

2024/102
Protocol Version 1.0, 12 February 2024

Date 16-02-2024

To,
The Chairperson / Member-Secretary
Institutional Ethics Committee (IEC),
Dr D.Y. Patil Medical College, Hospital & Research Center
Department of Pharmacology
5th Floor, D Y Patil University School of Medicine
Sector-5, Nerul, Navi Mumbai – 400 706
Phone No: 022 2770 2218 Extn.: 166
Mail: [email protected] or [email protected]

Subject: Research Proposal and documents for review and approval by the IEC
Study title: Evaluation of Efficacy and Safety of Galact® Granules (Shatavari Formulation) as a
Galactagogue in Post-partum Women: A Prospective, Randomized, Double-blind,
Placebo-Controlled Study (Protocol No. Galactagogue-1089-2024-01)

Dear Sir/Madam,
With reference to the above subject and reference, please find attached the following study related
documents for review and approval by Institutional Ethics Committee (IEC):

Sr. Document No. of

copies
1. Study Protocol No. Galactagogue-1089-2024-01, Version no. 1; dt. 12th Feb. 2024 3
2. Case Report Form (CRF) Version no.1; dt. 13th Feb. 2024 3
3. Informed Consent Document (PIS and ICF) in English Version no.1; dt. 15th Feb. 2024 3
4. Informed Consent Document (PIS and ICF) in Hindi (translated from English) Version 3
no. 1.0; dt. 13th Feb. 2023 and Back Translation Version no.1; dt. 15th Feb. 2024
5. Informed Consent Document (PIS and ICF) in Marathi (translated from English) Version 3
no. 1.0; dt. 13th Feb. 2023 and Back Translation Version no.1; dt. 15th Feb. 2024
6. FDA license Galact granules 3
7. Product profile Galact granules 3
I hereby state that I would conduct my research as per the applicable rules and regulations, and
principles of Good Clinical Practice guidelines issued by the ICMR and comply with all required
regulations.
I request you to kindly review and approve the same.
Thanking you

Investigator: Dr. Ashvini Deshmukh

Designation: Associate Professor
Mail: [email protected]

Enclosed: As above
 IEC Ref. No. 2024/102
Protocol Version 1.0, 12 February 2024

UNDERTAKING

I/We agree to abide by the ethical guidelines for biomedical research on human subject (As
per the ICMR guidelines) while conducting the research project being submitted for Ethical
Committee consideration:

1. Project is essential for the advancement of knowledge and for the benefit of all.
2. Only subjects who volunteer for the project will be included. Their informed Consent
shall be obtained prior to commencement of research project, and subjects will be kept
fully appraised of all the consequences.
3. Privacy and confidentiality of the subjects shall be maintained and without the
consent of subjects no disclosure will be made.
4. Proper precautions shall be taken to minimize risk and prevent irreversible.
adverse effects.
5. Research will be conducted by professionally competent people.
6. Research will be conducted in a fair, honest, impartial, and transparent manner.
7. Researchers will be accountable for maintaining proper records.
8. Research will be conducted keeping in view the public interest at large.
9. Research reports, materials and data will be preserved (as per institutional
guidelines). Result of research will be made known through scientific publications.
10. Professional and moral responsibilities will be of the researchers, directly or
indirectly connected with the research.
11. Only those drugs which are approved by the Drug controller of India for a specific
Purpose will be used in the research project.

Date: 16th February 2024

Place: Nerul
 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

1. TITLE
CLINICAL STUDY PROTOCOL

PROTOCOL TITLE

Evaluation of Efficacy and Safety of Galact Granules

(Shatavari) as a Galactagogue in Post-partum Women:
A Prospective, Randomized, Double-blind, Placebo-
Controlled Study

Protocol No.: Galactagogue-1089-2024-01

Version 1; dt. 12th February 2024

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

CONTENTS
1. TITLE 1
2. SIGNATURE PAGE 5
3. CONTACT LIST 7
4. LIST OF FACILITIES 8
5. GLOSSARY OF ABBREVIATIONS 9
6. PROTOCOL SYNOPSIS 10
Early Withdrawal of Subjects ..............................................................................................12
7. STUDY SCHEDULE 15
8. INTRODUCTION AND BACKGROUND 16
9. PRODUCT INFORMATION 17
9.1 Dosage and Administration .......................................................................................................17
10. STUDY OBJECTIVES AND ENDPOINTS 17
10.1 Study Objectives........................................................................................................................17
10.1.1 Primary Objectives: ................................................................................................17
10.1.2 Secondary Objectives:.............................................................................................17
10.2 Study End-points: ......................................................................................................................17
10.2.1 Primary End Points: ...............................................................................................17
10.2.2 Secondary End Points: ............................................................................................17
11. METHODOLOGY 18
11.1 Selection of Study Population ....................................................................................................18
11.1.1 Inclusion Criteria ....................................................................................................18
11.1.2 Exclusion Criteria ...................................................................................................18
11.1.3 Early Withdrawal of Subjects.................................................................................18
11.1.4 Number of Subjects.................................................................................................19
11.1.5 Study Duration........................................................................................................19
11.1.6 Study Design ...........................................................................................................19
11.1.7 Study Overview .......................................................................................................19
11.2 STUDY ASSESSMENTS ............................................................................................................21
11.2.1 Demography ............................................................................................................21
11.2.2 Medical/Surgical History ........................................................................................21
11.2.3 Physical Examination..............................................................................................21
11.2.4 Vital Signs ...............................................................................................................21
11.2.5 Breast milk volume measurement ..........................................................................21
11.2.6 Time to noticeable breast fullness ...........................................................................21
11.2.7 Laboratory assessment ...........................................................................................21
11.2.8 Subjective satisfaction assessment ..........................................................................22
11.2.9 Self‐reported insufficient milk (SRIM) assessment by mother ..............................22
11.2.10 Episodes of infections in infants..............................................................................22
11.2.11 Infant weight measurement ....................................................................................22
11.2.12 Safety assessment- Adverse events..........................................................................22
11.3 STUDY TREATMENT ...............................................................................................................23
11.3.1 Investigational Products (IPs)/ Study Products ......................................................23
11.3.2 Assessment of Compliance for Dosing ....................................................................24
11.3.3 Prohibited Medications/Treatments .......................................................................24
11.4 ADVERSE EVENTS ..................................................................................................................24
11.4.1 Definitions (AE, SAE, Unexpected AEs, etc.) .........................................................24
11.4.2 Collection of AEs.....................................................................................................24
11.4.3 Follow-Up of AEs ....................................................................................................25
11.4.4 Serious/Unexpected Adverse Events .......................................................................25
11.4.5 Other Significant Adverse Events...........................................................................26
11.4.6 Expedited Safety Reporting ....................................................................................26
11.5 ETHICAL CONSIDERATIONS..................................................................................................26
11.5.1 Ethics Committee ....................................................................................................26

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 Protocol #: Galactagogue-1089-2024-01
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11.5.2 Informed Consent ...................................................................................................26
11.5.3 Insurance for the Subjects ......................................................................................26
11.6 STATISTICAL METHODS AND DATA ANALYSIS ....................................................................27
11.6.1 Sample Size Consideration .....................................................................................27
11.6.2 Analysis Sets............................................................................................................27
11.6.3 Randomization ........................................................................................................27
11.6.4 Blinding and unblinding procedure........................................................................27
11.6.5 Baseline Definition ..................................................................................................27
11.6.6 Missing Data ...........................................................................................................28
11.6.7 Summary of Subject Disposition.............................................................................28
11.6.8 Demographics, Baseline Characteristics and Medical History ..............................28
11.6.9 Treatments compliance ...........................................................................................28
11.6.10 Efficacy and Safety Analysis ...................................................................................28
12. DOCUMENTATION 28
12.1 Supplementary Documentation ..................................................................................................28
12.2 Quality Assurance Audits ..........................................................................................................28
12.3 Accessibility ..............................................................................................................................28
12.4 Confidentiality of Data ..............................................................................................................29
12.5 Archives ....................................................................................................................................29
12.6 Publication Policy .....................................................................................................................29
13. ANNEXURES 30
14. REFERENCES 34

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 Protocol #: Galactagogue-1089-2024-01
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List of Annexures
Annexure 1: Case Record Form (CRF) ............................................................................................ 30
Annexure 2: Informed Consent Document (ICD) ............................................................................. 30
Annexure 3: Product profile: Galact granules ................................................................................... 30
Annexure 4: FDA license: Galact granules....................................................................................... 30
Annexure 5: Declaration of Helsinki (WMA)................................................................................... 30
Annexure 6: Study Schedule ............................................................................................................ 30
Annexure 7: Draft CTRI .................................................................................................................. 30
Annexure 8: Self‐reported insufficient milk (SRIM) assessment by mother ...................................... 30
Annexure 9: Subject Diary – Medication compliance ....................................................................... 30
Annexure 10: Expression (automatic) of breast milk: Procedure....................................................... 31
Annexure 11: Hand expression of breast milk: FAQs ....................................................................... 33

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

2. SIGNATURE PAGE

STUDY TITLE

Evaluation of Efficacy and Safety of Galact Granules

(Shatavari Formulation) as a Galactagogue in Post-partum
Women: A Prospective, Randomized, Double-blind, Placebo-
Controlled Study

INVESTIGATOR’S DECLARATION

I, the undersigned, have read and understood this protocol and hereby agree to conduct the
study in accordance with this protocol and to comply with all requirements regarding the
obligations of Investigators and all other Subject requirements of ICH-E6 R3 Guideline 2023
on ‘Good Clinical Practice’, New Drugs and Clinical Trials 2019, Declaration of Helsinki
(Taipei 2016) and any other applicable regulations.
I further agree to ensure that all associates assisting in the conduct of study are informed
regarding their obligations.

PRINCIPAL INVESTIGATOR

__________________________________ ____________________
Signature Date (DD/MM/YYYY)

Name : Dr. Ashvini Deshmukh

Address : Associate Professor,
Department of Obstetrics and Gynecology,
DY Patil Medical College and Hospital,
Nerul, Navi Mumbai 400706, Maharashtra.

Telephone : +91 99701 23758

E mail : [email protected]

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

PROTOCOL APPROVAL & SIGNATURE PAGE

Evaluation of Efficacy and Safety of Galact Granules (Shatavari

Formulation) as a Galactagogue in Post-partum Women: A Prospective,
Randomized, Double-blind, Placebo-Controlled Study

Protocol No.: Galactagogue-1089-2024-01

I have reviewed the foregoing protocol for the study no. Galactagogue-1089-2024-01. To the
best of my knowledge, the protocol is accurate and complete.
I approve this version as the final copy and consider it acceptable for regulatory submission.
I agree to comply with all requirements regarding the Sponsor's obligations and all other
Subject requirements of ICH-E6 R3 Guideline 2023 on ‘Good Clinical Practice’, New Drugs
and Clinical Trials 2019, Declaration of Helsinki (Taipei 2016), and any other applicable
regulations.

Approved by

____________________________ ________________
Authorized Signatory Date

Name : Dr. Ashvini Deshmukh

Address : Associate Professor, Department of Obstetrics and Gynecology,
DY Patil Medical College and Hospital, Nerul,
Navi Mumbai 400706, Maharashtra.
Telephone : +91 99701 23758
E mail : [email protected]

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 Protocol #: Galactagogue-1089-2024-01
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3. CONTACT LIST

Principal Investigator Name : Dr. Ashvini Deshmukh

Address : Associate Professor,
Department of Obstetrics and Gynecology,
D Y Patil Medical College and Hospital, Nerul, Navi
Mumbai 400706, Maharashtra.
Telephone : +91 99701 23758
E mail : [email protected]

Co-Investigator Name : Vd. Kalpana Dhuri

Address : D Y Patil University School of
Ayurveda, Nerul, Navi Mumbai 400706,
Maharashtra.
Telephone : +91 93218 35616
E mail : [email protected]
Contact Personnel (Overall)/ Name : Dr Prajakta Wangikar, PhD
Expedited Safety Reporting: Address : Manager, Medical Services,
Emcure Pharmaceuticals Ltd., Oberoi Garden
Estates, Yadav Nagar, Chandivali, Powai, Mumbai
400072, Maharashtra.
Telephone : +91 97698 51047
E mail : [email protected]

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 Protocol #: Galactagogue-1089-2024-01
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4. LIST OF FACILITIES

Clinical facility/Investigational Sites:

Sr. Study Site Address

1 Department of Obstetrics and Department of Obstetrics and Gynecology, DY
Gynecology. Patil Medical College and Hospital, Nerul,
Navi Mumbai 400706, Maharashtra.

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 Protocol #: Galactagogue-1089-2024-01
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5. GLOSSARY OF ABBREVIATIONS

AE Adverse Event
ANOVA Analysis of Variance
BMI Body Mass Index
CI Confidence Interval
COA Certificate of Analysis
CRF Case Report Form
CRO Contract Research Organization
EC Ethics Committee
GCP Good Clinical Practice
ICD Informed Consent Document
ICF Informed Consent Form
ICH International Council on Harmonization
IP Investigational Product
ITT Intent-To-Treat
OPD Outpatient Department
PP Per Protocol
SAE Serious Adverse Event
SD Standard Deviation
SOC Standard of Care
SOP Standard Operating Procedure
TEAE Treatment Emergent Adverse Event
TESAE Treatment Emergent Serious Adverse Event

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 Protocol #: Galactagogue-1089-2024-01
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6. PROTOCOL SYNOPSIS

Study Title Evaluation of Efficacy and Safety of Galact® Granules (Shatavari) as a

Galactagogue in Post-partum Women: A Prospective, Randomized,
Double-blind, Placebo-Controlled Study
Protocol Number Galactagogue-1089-2024-01 (Version 1.0)
Aim To assess the milk quantity (early enhancement and sustained
improvement) and quality parameters with administration of
Shatavari formulation (Galact ® granules) in post-partum women.
Investigational Test product:
Medicinal Product Each 100 gm of Galact ® granules contains extracts from:
Shatavari (Asparagus racemosus) 15 g, Vidari Kand (Pueraria
tuberose) 1 g, Sowa (Anethum Sowa) 1 g, Gokhru Panchang
(Tribulus terrestris) 2.5 g, Yashtimadhu (Glycyrrhiza glabra) 1 g,
Jeera (Safed) (Cuminum cyminum) 1 g, Ahliv powder (Lepidium
sativum) 1 g, with Cardamom (Elettaria cardamomum) flavor.
It should be taken as 2 teaspoons twice daily with one glass of
milk.
Reference product:
The reference product contains protein mixture without plant
extracts. The reference product is identical to the test product to
provide blinding.
It should be taken as 2 teaspoons twice daily with one glass of
milk.
Objectives Primary objective
1. To evaluate the efficacy of Galact® Granules in increasing breast
milk output during immediate post-partum period.
Secondary objectives
1. To evaluate the efficacy of Galact® Granules in increasing breast
milk output during post-partum period.
2. To evaluate the efficacy of Galact® Granules on improvement in
milk quality during the post-partum period.
3. To evaluate the efficacy of Galact® Granules on prolactin hormone
level during the post-partum period.
4. To evaluate the efficacy of Galact® Granules on subjective
satisfaction by mother during the post-partum period.
5. To evaluate the efficacy of Galact® Granules to prevent infections
in infants during the post-partum period.
6. To evaluate the efficacy of Galact® Granules on infant weight
during the post-partum period.
7. To evaluate the need for formula feed with the use of Galact®
Granules during the post-partum period.
8. To evaluate the safety of Galact® Granules during the post-partum
period in women.

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 Protocol #: Galactagogue-1089-2024-01
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Study Endpoints Primary Endpoints [Time Frame: Day 3- 72 hours]

1. Total volume (ml) of breast milk produced on the third post-partum
day; Measurement by Breast pump (Manual/Automatic).
2. Mean time (hours) to evident noticeable breast fullness after
delivery.
Secondary Endpoints
1. Total volume (ml) of breast milk produced after breast fullness;
measurement by breast pump (Manual/Automatic) [Time Frame:
Week 4, Week 16]
2. Mean change in protein content (albumin and globulin) and specific
gravity in breast milk during post-partum women after delivery.
[Time Frame: Baseline, Week 4, Week 16]
3. Mean change in serum prolactin levels in post-partum women after
delivery. [Time Frame: Baseline, Week 4, Week 16]
4. Mean time (hours) to evident noticeable breast fullness after last
breast feeding (measured during daytime). [Time Frame: Week 4,
Week 16]
5. Subjective assessments on time to noticeable breast fullness after
delivery using five-point Likert scale. [Time Frame: Day 3- 72
hours, Week 4, Week 16]
6. Use of infant formula feed. [Time Frame: Week 4, Week 16]
7. Self‐reported insufficient milk (SRIM) assessment by mother for
their decision to wean their infant. [Time Frame: Week 4, Week 16]
8. Proportion of infants developing infections. [Time Frame: Week 4,
Week 16]

9. Mean change in infant weight after delivery. [Time Frame: Day 3-

72 hours, Week 4, Week 16]
10. Proportion of women experiencing Treatment-Emergent Adverse
Events (TEAEs). [Time Frame: Baseline, Week 4, Week 16]
11. Proportion of women experiencing Treatment-Emergent Serious
Adverse Events (TESAEs). [Time Frame: Baseline, Week 4, Week
16]
Study Design Prospective, randomized, double-blind, placebo-controlled study
Study Population A total sample of 110 women (55 in each group) will be included in the
study with 1:1 randomization.
Study Duration Study duration will be 16 weeks for each woman participant.
Inclusion Criteria 1. Healthy women between 20-45 years of age.
2. Women with uncomplicated full-term delivery (vaginal or LSCS).
3. Women who have accomplished antenatal breastfeeding
promotion protocol immediately post-partum or within three days
of delivery.
4. Women able to understand the study requirements and follow
other procedures required by the study protocol.
5. Must have the ability and willingness to sign an informed consent
and to comply with all study procedures.

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 Protocol #: Galactagogue-1089-2024-01
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Exclusion Criteria 1. Post-partum women with contraindications to breastfeeding, such

as HIV, chemotherapeutic drugs, radioactive substances, and
babies with galactosemia.
2. Post-partum women with unstable conditions (i.e., post-partum
hemorrhage, sepsis).
3. Women with known allergies to Shatavari or other ingredients of
Galact granules.
4. Women already using products that have galactagogue properties.
5. Women whose babies require phototherapy, women with
insufficient glandular tissue or breast surgery and any structural
abnormality of the breast.
6. Women with a history of infertility, known hypothyroidism,
women with twins, or higher-order births.
7. Any known clinically significant endocrine, metabolic, hepatic,
renal, cardiovascular, gastrointestinal, respiratory, hematological,
or neurological illnesses or the presence of any current psychiatric
disorders in women will be considered as exclusion criteria.
8. If any other investigational drug was used within three months
before the entry in this study or those who cannot be relied upon
to comply with the test procedures or are unwilling to give
informed consent will be excluded.
Early Withdrawal Participants can be withdrawn from the study at any time for any of the
of Subjects following reasons:
• Voluntary withdrawal of consent
• Certain adverse events at the discretion of Clinical Investigator
• The discovery of an unexpected, significant, or unacceptable risk
to the subjects enrolled in the study
• Significant non-compliance with the study procedure by the
subject
• Protocol violation
• Any other reason that may affect the outcome of the study or
safety of the subjects
• Termination of the study
Study Ethics This study will be conducted according to the requirements of the ICH-
E6 R2 Guideline (2016) on ‘Good Clinical Practice’, New Drugs and
Clinical Trials 2019, Declaration of Helsinki (Taipei 2016), and any
other applicable regulations.
Ethics Committee approval will be obtained and CTRI registration will
be done before initiating the study.
Participant’s written informed consent will be taken prior to any study
procedure being conducted.
Methodology 1. All eligible women who meet the inclusion and exclusion criteria
will be part of the study.
2. Participants will be informed about the purpose of the study and
signed informed consent will be taken.
3. All participants will be followed-up during the study period (visit 1
(screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (Day
3- 72 hours after delivery), visit 3 (week 4) ± 4 days, visit 4 (week
16) ± 4 days.
4. The adverse events, either spontaneously reported by the
participant, or noticed by the clinician will be recorded during the
study.
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 Protocol #: Galactagogue-1089-2024-01
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Study Schedule Visit 1: Baseline visit- day 1

− Informed consent process
− Inclusion/exclusion criteria (eligibility)
− Demography& medical history
− Physical examination and vital signs
− Laboratory assessment (prolactin and physicochemical parameters)
− Study Medication Dispensing
− Concomitant Medication
− Baseline Adverse Events (AE)
Visit 2: Day 3- 72 hours after delivery
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Subjective assessment for breast fullness
− Infant weight measurement
− Concomitant Medication
Visit 3: (Week 4 ± 4 Days)
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Laboratory assessment (prolactin and physicochemical parameters)
− Subjective assessment for breast fullness
− Self‐reported insufficient milk (SRIM) assessment by mother
− Infant weight measurement
− Episodes of illness in infants since last visit
− Need for infant formula feed
− Concomitant Medication
− AE and SAE
Visit 4: (Week 16 ± 4 Days)
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Laboratory assessment (prolactin and physicochemical parameters)
− Subjective assessment for breast fullness
− Self‐reported insufficient milk (SRIM) assessment by mother
− Infant weight measurement
− Episodes of illness in infants since last visit
− Need for infant formula feed
− Compliance Assessment
− Concomitant Medication
− AE and SAE
− Study Completion/Termination

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 Protocol #: Galactagogue-1089-2024-01
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Statistical Analysis Sample size

A total of 110 women will be enrolled (55 in each group).
Analysis dataset
All analysis would be done on both intent-to-treat (ITT) and per-
protocol (PP) datasets. The ITT dataset would include all patients
recruited in the study who had taken at least one dose of Investigational
Product and had given at least one post-baseline assessment,
irrespective of their study completion status, whereas the PP dataset
would include all patients who completed the study as per the protocol
without any protocol violation.
Data expression
Measurement data for total scores for Subjective assessment, will be
presented as means with SD. Ranking data and scores would be
calculated and presented as means with SD. 95% confidence intervals
(C.I.) would be presented wherever applicable. Categorical and nominal
data will be presented as number with percentages. Change in the scores
from visit 1 would be calculated and expressed as means with SD.
Analysis methods
Baseline values and scores will be compared to post-treatment values
and score for the different scales using the repeat measures ANOVA for
normally distributed data and Friedman test for non-normal data. Post-
hoc individual comparisons will be done using t-test for normal data and
Wilcoxon test for non-normal data. Between groups comparisons will
be done using the One-Way ANOVA for normal data and
Kruskal00Wallis test for non-normal data.
Nominal data will be compared between the groups using chi-square
test.
All testing would be done using two-sided tests at alpha 0.05.

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7. STUDY SCHEDULE
Visit Visit 2
Visit 1 (Day 3- Visit 3 Visit 4
Sr. (Baseline- 72 hours (Week 4 (Week 16
Activities day 1) after ± 4 days) ± 4 days)
delivery )
1. Informed consent process √ X X X
2. Inclusion/exclusion criteria (eligibility) √ X X X
3. Demography& medical history √ X X X
4. Physical examination and vital signs √ √ √ √
5. Breast milk volume measurement X √ √ √
Laboratory assessment (prolactin and X
6. √ √ √
physicochemical parameters)
7. Time to noticeable breast fullness X √ √ √
Subjective assessment for breast X √ √ √
8.
fullness
Self‐reported insufficient milk (SRIM) X √ √ √
9.
assessment by mother
10. Infant weight measurement X √ √ √
11. Episodes of illness since previous visit X X √ √
12. Study Medication Dispensing √ X X X
13. Concomitant Medication √ √ √ √
14. Compliance Assessment# X X X √
15. AE and SAE √ X √ √
16. Study Completion/Termination X X X √
#
Compliance will be assessed based on the medication (Capsule) count, and consumption of 80% or
more medication will be considered as compliant.

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8. INTRODUCTION AND BACKGROUND

The postpartum period begins soon after the delivery of the baby and usually lasts six to eight
weeks and ends when the mother's body has nearly returned to its pre-pregnant state. The
postpartum period can be divided into three distinct stages; the initial or acute phase, 8–19
hours after childbirth; subacute postpartum period, which lasts two to six weeks, and the
delayed postpartum period, which can last up to six months. Postpartum breastmilk is the ideal
food for infants. It is safe, clean and contains antibodies which help protect against many
common childhood illnesses.1
Lactogenesis (milk production) is a complex neurophysiological process that involves the
action of a number of hormones, mainly prolactin. Prolactin is secreted by the anterior pituitary
gland in response to nipple stimulation. It is under inhibitory control from the hypothalamus,
which is mediated by dopamine.2 During the first six months of life, breast milk is the optimal
source of nutrition for babies. The most common cause of breastfeeding failure is insufficient
production of breast milk which is also known as lactational inadequacy. This may occur in
various circumstances, such as illness of the mother or the child, mother–baby separation,
preterm birth, anxiety, fatigue and emotional stress. Although milk production can be increased
by relaxation techniques and psychological support, many mothers tend to use medications or
other products to increase their lactation.3
Galactagogue medicines, such as metoclopramide, oxytocin, domperidone, chlorpromazine
and sulpiride, are among the current therapeutic strategies in healthy mothers. However, these
medications are associated with adverse effects, such as extrapyramidal symptoms, arrhythmia,
and iatrogenic hyperthyroidism in mother or infant. Therefore, alternative therapies have been
under investigation. Herbal medications have shown the potential for safe and effective
treatment for milk production in post-partum women.4
Shatavari (Asparagus racemosus), also known as "wild asparagus", is a plant native to the
Indian subcontinent and used as ayurvedic medicinal herb that plays a vital role in enhancing
the production of milk and prevention and treatment of physical and emotional stress. Shatavari
is known as the “Queen of Ayurvedic herbs”. It has a long history of use as a galactagogue in
India and is also included in the official ayurvedic pharmacopeia for this use. The primary
active constituents of A. racemosus are steroidal saponins found in the roots. It is loaded with
folic acid, vitamins A, C, and K, and phytoestrogens; the hormonal effect of phytoestrogens is
like estrogen in milk production.5 A key regulator of prolactin production is estrogens which
enhance the growth of prolactin-producing cells and stimulate prolactin production directly, as
well as by suppressing dopamine. It also contains tryptophan, an essential amino acid that may
stimulate prolactin production, leading to increased milk production.6
This herb has a variety of different names, including wild asparagus, Satawar, Satamuli, and
Shatavari. The root is the primary medicinal part of the plant. Like classic asparagus, it has a
thick root (or rhizome) that is harvested. Shatavari has more than 50 organic compounds
including steroidal saponins, glycosides, alkaloids, polysaccharides, mucilage, racemosol, and
isoflavones. The primary active constituents of A. racemosus are steroidal saponins found in
the roots.7 Shatavari is commonly available in the form of tablets, capsules, or powder. So far,
studies including randomized controlled trials support use of shatavari as a galactagogue for 4-
6 weeks.8 However, long term efficacy of shatavari for this indication has not been explored
yet. This study aims to investigate the potential benefits of Galact Granules (Shatavari
Formulation) as a Galactagogue in post-partum woman for milk production.

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9. PRODUCT INFORMATION
9.1 Dosage and Administration
Subjects will be asked to consume 2 teaspoons powder of Galact granules (containing Shatavari
(Asparagus racemosus) 15 g, Vidari Kand (Pueraria tuberose) 1 g , Sowa (Anethum Sowa) 1
g, Gokhru Panchang (Tribulus terrestris) 2.5 g, Yashtimadhu (Glycyrrhiza glabra) 1 g, Jeera
(Safed) (Cuminum cyminum) 1 g, Ahliv powder (Lepidium sativum) 1 g, with Elaichi flavor)
or placebo/reference product (containing protein mixture without of Galact granules) twice
daily with one glass of milk for 16 weeks.

10. STUDY OBJECTIVES AND ENDPOINTS

10.1 Study Objectives

10.1.1 Primary Objectives:

1. To evaluate the efficacy of Galact Granules in increasing breast milk output during
immediate post-partum period.

10.1.2 Secondary Objectives:

1. To evaluate the efficacy of Galact® Granules in increasing breast milk output during post-
partum period.
2. To evaluate the efficacy of Galact® Granules on improvement in milk quality during the
post-partum period.
3. To evaluate the efficacy of Galact® Granules on prolactin hormone level during the post-
partum period.
4. To evaluate the efficacy of Galact® Granules on subjective satisfaction by mother during
the post-partum period.
5. To evaluate the efficacy of Galact® Granules to prevent infections in infants during the
post-partum period.
6. To evaluate the efficacy of Galact® Granules on infant weight during the post-partum
period.
7. To evaluate the need for formula feed with the use of Galact® Granules during the post-
partum period.
8. To evaluate the safety of Galact® Granules during the post-partum period in women.

10.2 Study End-points:

10.2.1 Primary End Points:

1. Total volume (ml) of breast milk produced on the third post-partum day; Measurement by
Breast pump (Manual/Automatic). [Time Frame: Day 3- 72 hours]
2. Mean time noticeable from birth to evident breast fullness after delivery. [Time Frame: Day
3- 72 hours]

10.2.2 Secondary End Points:

1. Total volume (ml) of breast milk produced after breast fullness; measurement by breast
pump (Manual/Automatic) [Time Frame: Week 4, Week 16]
2. Mean change in protein content (albumin and globulin) and specific gravity in breast milk
during post-partum women after delivery. [Time Frame: Baseline, Week 4, Week 16]
3. Mean change in serum prolactin levels in post-partum women after delivery. [Time Frame:
Baseline, Week 4, Week 16]

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4. Mean time (hours) to evident noticeable breast fullness after last breast feeding (measured
during daytime). [Time Frame: Week 4, Week 16]
5. Subjective assessments on time to noticeable breast fullness after delivery using five-point
Likert scale. [Time Frame: Day 3- 72 hours, Week 4, Week 16]
6. Use of infant formula feed. [Time Frame: Week 4, Week 16]
7. Self‐reported insufficient milk (SRIM) assessment by mother for their decision to wean
their infant. [Time Frame: Week 4, Week 16]
8. Proportion of infants developing infections. [Time Frame: Week 4, Week 16]
9. Mean change in infant weight after delivery. [Time Frame: Day 3- 72 hours, Week 4, Week
16]
10. Proportion of women experiencing Treatment-Emergent Adverse Events (TEAEs). [Time
Frame: Baseline, Week 4, Week 16]
11. Proportion of women experiencing Treatment-Emergent Serious Adverse Events
(TESAEs). [Time Frame: Baseline, Week 4, Week 16]
11. METHODOLOGY
11.1 Selection of Study Population
11.1.1 Inclusion Criteria
1. Healthy women between 20-45 years of age
2. Women with uncomplicated full-term delivery (vaginal or LSCS).
3. Women who have accomplished antenatal breastfeeding promotion protocol
immediately post-partum or within three days of delivery.
4. Women able to understand the study requirements and follow other procedures
required by the study protocol.
5. Must have the ability and willingness to sign an informed consent and to comply with
all study procedures.
11.1.2 Exclusion Criteria
1. Post-partum women with contraindications to breastfeeding, such as HIV,
chemotherapeutic drugs, radioactive substances, and babies with galactosemia.
2. Post-partum women with unstable conditions (i.e., post-partum haemorrhage, sepsis).
3. Women with known allergies to Shatavari or other ingredients of Galact granules.
4. Women already using products that have galactagogue properties.
5. Women whose babies require phototherapy, women with insufficient glandular tissue
or breast surgery and any structural abnormality of the breast.
6. Women with a history of infertility, known hypothyroidism, women with twins, or
higher-order births.
7. Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular,
gastrointestinal, respiratory, hematological, or neurological illnesses or the presence of
any current psychiatric disorders in women will be considered as exclusion criteria.
8. If any other investigational drug was used within three months before the entry in this
study or those who cannot be relied upon to comply with the test procedures or are
unwilling to give informed consent will be excluded.
11.1.3 Early Withdrawal of Subjects
Subject can be withdrawn from the study at any time for any of the following reasons:
- Voluntary withdrawal of consent
- Certain adverse events at the discretion of Clinical Investigator
- The discovery of an unexpected, significant, or unacceptable risk to the subjects enrolled
in the study
- Significant non-compliance with the study procedure by the subject
- Protocol violation

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- Any other reason that may affect the outcome of the study or safety of the subjects
- Termination of the study
Reasons for the discontinuation by the subject from the clinical trial will be documented
appropriately, along with any referrals that are made. In case of premature treatment
withdrawal, the End of study procedures will be performed.
11.1.4 Number of Subjects
110 eligible subjects will be enrolled in a 1:1 ratio into two treatment arms (55 in each group).
11.1.5 Study Duration
Total study duration will be approximately 16 weeks for each woman participant.
11.1.6 Study Design
Prospective, randomized, double-blind, placebo-controlled study.
11.1.7 Study Overview
The subject population consists of healthy women between 20-45 years of age fulfilling
eligibility criteria.
Participants will be enrolled into the study based on Inclusion & Exclusion Criteria, medical
history, and safety measures. The duration of each participant’s participation in the study will
be 16 weeks.
Visit 1 (Screening /Baseline- Day 1)
Visit 2 (Day 3- 72 hours after delivery)
Visit 3 (Week 4 ± 4 Days)
Visit 4 (Week 16 ± 4 Days)
Window period of ± 4 day is applicable for visit 2, 3, and 4.
During Screening, Day 1, informed consent will be obtained before any study procedures take
place. After the consent process, baseline characteristics such as medical/surgical history, will
then be documented, including the concomitant medications. All participants will undergo the
screening procedure to determine whether they are meeting the required inclusion and
exclusion criteria.
Following assessments will be recorded during this Visit 1: Screening and enrollment
(Baseline: Day 1)
− Informed consent process
− Inclusion/exclusion criteria (eligibility)
− Demography& medical history
− Physical examination and vital signs
− Laboratory assessment (prolactin and physicochemical parameters)
− Study Medication Dispensing
− Concomitant Medication
− Baseline Adverse Events (AE)
All eligible women participants (labelled as ‘subjects’ here onwards), will be given required
quantity of study medication for self-administration, sufficient till the Visit 4 (End of study
visit). Subjects will be randomized to either one of the two treatment arms. They will be
dispensed medications as per the randomized schedule in the following manner:
• Test product:

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Each 100 gm of Galact granules contains extracts from: Shatavari (Asparagus racemosus)
15 g, Vidari Kand (Pueraria tuberose) 1 g , Sowa (Anethum Sowa) 1 g, Gokhru Panchang
(Tribulus terrestris) 2.5 g, Yashtimadhu (Glycyrrhiza glabra) 1 g, Jeera (Safed)
(Cuminum cyminum) 1 g, Ahliv powder (Lepidium sativum) 1 g, with Elaichi flavor. It
should be taken as 2 teaspoons twice daily with one glass of milk.
• Reference product:
The reference product contains protein mixture without of Galact granules that should be
taken as 2 teaspoons twice daily with one glass of milk.

Subjects will be asked to consume 2 teaspoons powder of Galact granules (containing Shatavari
(Asparagus racemosus) 15 g, Vidari Kand (Pueraria tuberose) 1 g , Sowa (Anethum Sowa) 1
g, Gokhru Panchang (Tribulus terrestris) 2.5 g, Yashtimadhu (Glycyrrhiza glabra) 1 g, Jeera
(Safed) (Cuminum cyminum) 1 g, Ahliv powder (Lepidium sativum) 1 g, with Elaichi flavor)
or placebo/reference product (containing protein mixture without shatavari) twice daily with
one glass of milk for 16 weeks. Subjects will be asked to visit the site for Visit 2 (Day 3- 72
hours after delivery), Visit 3 (Week 4), and Visit 4 (Week 16).

Following assessments will be done during this Visit 2: (Day 3- 72 hours after delivery)
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Subjective assessment
− Infant weight measurement
− Concomitant Medication
Following assessments will be done during this Visit 3: (Week 4 ± 4 Days)
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Laboratory assessment (prolactin and physicochemical parameters)
− Subjective assessment for breast fullness
− Self‐reported insufficient milk (SRIM) assessment by mother
− Infant weight measurement
− Episodes of illness in infants since last visit
− Need for infant formula feed
− Concomitant Medication
− AE and SAE
Following assessments will be done during this Visit 4: (Week 16 ± 4 Days)
− Physical examination and vital signs
− Breast milk volume measurement
− Time to noticeable breast fullness
− Laboratory assessment (prolactin and physicochemical parameters)
− Subjective assessment for breast fullness
− Self‐reported insufficient milk (SRIM) assessment by mother
− Infant weight measurement
− Episodes of illness in infants since last visit
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− Need for infant formula feed

− Compliance Assessment
− Concomitant Medication
− AE and SAE
− Study Completion/Termination
Adverse events and concomitant medication will be recorded throughout the study. Subjects
will be asked to get used and unused study medications on this visit.
11.2 STUDY ASSESSMENTS
11.2.1 Demography
Demographic characteristics include age, height, weight, BMI. This assessment will be done
at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1).
11.2.2 Medical/Surgical History
Medical history [Relevant medication history (prior or preexisting conditions), recent surgical
history and current medical condition] will be recorded at Visit 1, Screening Visit/ Enrolment
Visit/ Baseline Visit, (Day 1). Any event or change in the participant’s condition or health
status occurring before the initial study drug administration will be recorded appropriately.
11.2.3 Physical Examination
A physical examination will be performed at each visits and at other times as per investigator’s
discretion. This evaluation will include an examination of (but should not be limited to) general
appearance, head and neck, cardiovascular system, respiratory system, gastrointestinal system,
and nervous system, etc. Information about the physical examination will be recorded by the
investigator or designee appropriately. Physical examination may be performed during the
study treatments, as clinically indicated. Clinically significant findings and illnesses meeting
the definition of AE will be documented appropriately. Determination of clinical significance
and seriousness will be based on the investigators’ medical judgment.
11.2.4 Vital Signs
Vital signs: B.P. and pulse rate (supine posture), body temperature and respiration rate (in
supine posture) will be assessed and documented at each visits and at other times as per the
discretion of the Investigator.
11.2.5 Breast milk volume measurement
Milk volume will be measured after the breast milk expression from both breasts using a breast
pump. An electric breast pump with three-phase pumping, which includes massage, stimulation,
and expression, will be used. Manual extraction will be done in case of failure to use a breast
pump.
Milk volume measurement will be done at Visit 2 (Day 3- 72 hours after delivery), Visit 3
(Week 4), and Visit 4 (Week 16).
11.2.6 Time to noticeable breast fullness
Time to evident breast fullness is defined as the mean time from birth to evident breast fullness.
The participants will be asked if they noticed their breasts were full, followed by the question:
"When did you feel breast fullness?" and accordingly time will be measured.
Time to noticeable breast fullness will be done at Visit 2 (Day 3- 72 hours after delivery), Visit
3 (Week 4), and Visit 4 (Week 16).
11.2.7 Laboratory assessment
Blood samples will be collected from the participants to measure the following parameters:

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- Serum prolactin hormone level and,

Breast milk samples will be collected from the participants to measure the following
parameters:
- Total protein content
- Albumin
- Globulin
- Special gravity level
Laboratory assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline
Visit- Day 1), Visit 3 (Week 4), and Visit 4 (Week 16).
11.2.8 Subjective satisfaction assessment
Subjective assessment on time to noticeable breast fullness will be assessed after delivery using
five-point Likert scale where participants will be asked to rate their level of satisfaction of
breast fullness using following point:
1. Very satisfied
2. Satisfied
3. Neutral (Neither satisfied nor dissatisfied)
4. Unsatisfied
5. Very unsatisfied
Subjective assessment will be done at Visit 2 (Day 3 - 72 hours after delivery), Visit 3 (Week
4), and Visit 4 (Week 16).
11.2.9 Self‐reported insufficient milk (SRIM) assessment by mother
Statements for mother's decision to wean their infant will be recorded by the mother on ‘Self‐
reported insufficient milk (SRIM)’ scale.9
SRIM will be assessed based on 5 statements recorded on 4-point Likert scale (1 [Not important
at all] – 4 [very important]):
1. Breast milk alone did not satisfy baby.
2. Baby was not gaining enough weight.
3. A health professional said baby was not gaining enough.
4. Mom had trouble getting the milk flow to start.
5. Mom did not have enough milk.
A higher score indicates greater insufficiency of breast milk.
11.2.10 Episodes of infections in infants
Details of any infective episodes (respiratory infections, gastrointestinal episodes, or febrile
episodes) occurring in infants will be recorded for the period since previous visit.
11.2.11 Infant weight measurement
Infant weight will be measured using a weighing machine. Place a thin piece of cloth or soft
paper into a pan scale. Lie the unclothed infant on the cloth or paper and wait for him/her to
stay still, to allow the scale to settle. Record the infant's weight to the nearest 0.1kg.
Infant weight measurement will be done at Visit 2 (Day 3- 72 hours after delivery), Visit 3
(Week 4), and Visit 4 (Week 16).
11.2.12 Safety assessment- Adverse events
Adverse events occurring during the study period will be monitored until satisfactory resolution
or stabilization. It will be recorded and managed appropriately. Concomitant medication
assessment will be done and recorded during the study.
The schematic representation of study assessment schedule is given below:

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Visit Visit 2
Visit 1 (Day 3- Visit 3 Visit 4
Sr. (Baseline- 72 hours (Week 4 (Week 16
Activities day 1) after ± 4 days) ± 4 days)
delivery)
1. Informed consent process √ X X X
2. Inclusion/exclusion criteria (eligibility) √ X X X
3. Demography& medical history √ X X X
4. Physical examination and vital signs √ √ √ √
5. Breast milk volume measurement X √ √ √
Laboratory assessment (prolactin and X
6. √ √ √
physicochemical parameters)
7. Time to noticeable breast fullness X √ √ √
Subjective assessment for breast X √ √ √
8.
fullness
Self‐reported insufficient milk (SRIM) X √ √ √
9.
assessment by mother
10. Infant weight measurement X √ √ √
11. Episodes of illness since previous visit X X √ √
12. Study Medication Dispensing √ X X X
13. Concomitant Medication √ √ √ √
14. Compliance Assessment# X X X √
15. AE and SAE √ X √ √
16. Study Completion/Termination X X X √

11.3 STUDY TREATMENT

11.3.1 Investigational Products (IPs)/ Study Products
Treatment Treatment product Ingredients
Test product Galact Granules 100 Powder containing Shatavari (Asparagus
mg powder (Shatavari racemosus) 15 g, Vidari Kand (Pueraria tuberose)
Formulation) as a 1 g , Sowa (Anethum Sowa) 1 g, Gokhru Panchang
Galactagogue (Tribulus terrestris) 2.5 g, Yashtimadhu
(Glycyrrhiza glabra) 1 g, Jeera (Safed) (Cuminum
cyminum) 1 g, Ahliv powder (Lepidium sativum) 1
g, with Elaichi flavor.
Reference Identical protein Powder containing identical protein mixture
product mixture 100 mg without contents of Galact granules.
powder without
shatavari

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Administration of IPs
Participants will be given medications as per the randomization schedule in a 1:1 ratio.
After all baseline assessments and post randomization, all participants will be given enough
quantity of medication that will be sufficient till the end of treatment (16 weeks).
11.3.2 Assessment of Compliance for Dosing
Enrolled participants will self-administer with the study medications as mentioned in the earlier
section. They will be asked to get used and unused study medications at Visit 4, End of study
Visit (Week 16). Adherence to the assigned regimen will be assessed by the study personnel
by recording the quantity/number of medication dispensed to the subject and returned by the
subjects at each visit. This will help to check the dosing compliance. Unused amounts will be
documented in respective logs.
11.3.3 Prohibited Medications/Treatments
The use of the current medications, over the counter products, by the participant must be
informed to the Investigator. Subjects will not be allowed any other forms of dietary
supplements/multivitamins or disease-specific oral nutrition supplements during the study. The
Investigator will decide whether to continue further with the subject of the assigned study. It
will be the decision of the Investigator about which drugs/ treatment to be prohibited for the
study subjects.

11.4 ADVERSE EVENTS

11.4.1 Definitions (AE, SAE, Unexpected AEs, etc.)
Adverse Event
It is any untoward medical occurrence in a clinical investigational Subject after administering
a pharmaceutical product; however, it may not necessarily have a causal relationship with this
treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign
(including an abnormal laboratory finding), symptom, or disease temporally associated with
the use of a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product.
Adverse Drug Reaction
In the pre-approval experience with a new medicinal product or its new usages, particularly as
the therapeutic dose(s) may not be established, all noxious and unintended responses to a
medicinal product related to any dose should be considered adverse drug reactions. The phrase
‘Clinical responses to a medicinal product’ means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship
cannot be ruled out.
Treatment Emergent Adverse Events (TEAEs)
Treatment emergent AEs will be defined as AEs with onset after administration of the study
drug, or when a preexisting medical condition increases in severity or frequency after study
drug administration.
11.4.2 Collection of AEs
The Subjects will be monitored for adverse events throughout the entire study period. They
will be queried on adverse events at each visit. All AEs spontaneously reported by the Subjects
or observed by the investigator will be recorded and managed and rated according to the
following definitions:
Intensity
The following three-point rating scale will be used for rating the intensity of each AE:

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Mild: Awareness of signs or symptoms, but no disruption of usual activity

Moderate: Event sufficient to affect usual activity (disturbing).

Severe: Inability to work or perform usual activities (unacceptable).

Causality
The following five-point scale will be used for rating the causal relationship of the AE to the
investigational product:
Unrelated: Clearly and incontrovertibly due only to extraneous causes, and does
not meet criteria listed under unlikely, possible, or probable.
Unlikely: Does not follow a reasonable temporal sequence from administration.
May have been produced by the Subject's clinical state or by
environmental factors or other therapies administered.
Possible: Follows a reasonable temporal sequence from administration. May
have been produced by the Subject's clinical state or by environmental
factors or other therapies administered.
Probable: Clear-cut temporal association with improvement on cessation of test
drug or reduction in dose.
Certain: Clear-cut temporal association with improvement on cessation of test
drug or reduction in dose. Reappears upon re-challenge. Follows a
known pattern of response to test drug.

11.4.3 Follow-Up of AEs

AEs requiring therapy must be treated by recognized standards of medical care to protect the
health and well-being of the Subject. Appropriate resuscitation equipment and medicines must
be available to ensure the best possible treatment of an emergency. The outcome of AEs will
be rated as:
• Complete recovery
• Incomplete recovery
• Recovered with sequalae.
• Unknown
• Death
11.4.4 Serious/Unexpected Adverse Events
Serious Adverse Event
Any untoward medical occurrence that at any dose:
• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity,
• or is a congenital anomaly/birth defect.

Unexpected Adverse Event

An adverse event, the nature or severity of which is not consistent with the applicable product
information (e.g., investigator's brochure for an investigational product or package
insert/summary of product characteristics for an approved product). The term ‘life-threatening’
refers to an event in which the Subject was at immediate risk of death at the time of the event.
It does not refer to an event which may have caused death if it were more severe.

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11.4.5 Other Significant Adverse Events

Other significant AEs are marked based on any AEs that lead to an intervention, including
withdrawal of drug treatment, dose reduction, or significant additional concomitant therapy. In
case of a drop-out Subject, discontinued because of an AE, such events will be followed by the
investigator until the event is resolved or until the medical condition of the Subject is stable
and all follow-up information collected will be made available to the Sponsor. Potentially
clinically serious AEs are types of AEs which may occur before starting treatment. Such AEs
may have clinical importance for Subject care, and which justify a particular supervision
because of their nature.
11.4.6 Expedited Safety Reporting
All serious AEs must be reported to the Sponsor and CRO within 24 hours from the time
occurrence of the SAE. Such events will be documented in the best possible detail on the
Serious Adverse Event Report Form to be transmitted to the SPONSOR and CRO by email:
Name : Dr Prajakta Wangikar, PhD
Address : Manager, Medical Services,
Emcure Pharmaceuticals Ltd.,
Oberoi Garden Estates, Yadav Nagar,
Chandivali, Powai, Mumbai 400072, Maharashtra.
Telephone : +91 97698 51047
E mail : [email protected]
Any such events will also be reported by the investigator to the Ethics Committee (EC) within
24 hours from the time of occurrence of the SAE. The investigator shall forward his report after
due analysis to the Head of the Institution (HOI), EC within 14 days of the knowledge of
occurrence of SAE of death.
11.5 ETHICAL CONSIDERATIONS
11.5.1 Ethics Committee
This study will be carried out in compliance with the ICH GCP E6 R2 2016 (Step 4), ‘Guidance
for Good Clinical Practices (GCP)’, New Drugs and Clinical Trials 2019 and Declaration of
Helsinki (Taipei 2016). The Ethics Committee shall review the protocol and the informed
consent form for this study and no study specific procedure will be carried out until a written
approval is obtained from the Ethics committee.
11.5.2 Informed Consent
Written informed consent will be obtained from the subject or a respective guardian before any
study-related procedures (including any pre-treatment procedures) is performed. The
investigator(s) has both ethical and legal responsibility to ensure that each subject being
considered for inclusion in this study is given a full explanation of the protocol. This will be
documented on a written informed consent form (provided in English or any other language as
per requirement i.e., whichever is applicable) which is EC approved. After essential
information has been provided to the Subject by the investigator, the Subject and the
investigator will sign the EC-approved written ICF. The Subject will be given a copy of the
signed ICF, and the original will be kept with the site.
11.5.3 Insurance for the Subjects
Sponsor will be responsible to bear the cost of medical management given to the subject in
case of any trial related injury or serious adverse event.

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11.6 STATISTICAL METHODS AND DATA ANALYSIS

11.6.1 Sample Size Consideration
Sample size is based on the primary study outcome, i.e. total volume (ml) of breast milk
produced on the third post-partum day after study therapy.
The reported milk volume at 72 hours post-partum with Shatavari based treatment and placebo
were 66.67 (25.2) ml and 52.35 (24.7) ml respectively with a mean difference of 14.32 between
study and reference.
Using a two-sample test for comparison of means, a sample size of 49 in each group will
provide 80% power with alpha 0.05 (95% confidence levels) in a two-sided test.
Considering additional 10% patients for data loss, a total sample of 110 women will be included
in the study with 1:1 randomization.
11.6.2 Analysis Sets
Safety Population: Safety population will comprise of the subjects who received at least one
dose of the study treatment.
Intent to Treat (ITT) Population: ITT population will comprise of the subjects who received at
least one dose of the study treatment and having at least one post baseline assessment for the
primary endpoint.
Per-Protocol (PP) Population: PP Population will comprise of all the subjects who received all
doses of study treatment and completed the study.
11.6.3 Randomization
Randomization schedule will be generated using PC based program Rando (Version 1.2, R.
Raveendran). After signing the informed consent, subjects will be assigned a unique screening
number. After eligibility of subjects is confirmed for the study, each subject will be assigned a
unique randomization number according to randomization schedule and accordingly,
treatments will be assigned. It is a double-blind study; hence, blinding is required. Subjects
will be assigned randomly as per the randomization schedule, in a 1:1 ratio to receive either of
the two treatments.
11.6.4 Blinding and unblinding procedure
Blinding procedure:
Both the study products will be of the same form and color. This will ensure that the subjects
as well as the investigator and the staff cannot differentiate between active/placebo treatments.
Blinded randomization codes will be maintained at the custody of investigator.
Unblinding procedure:
Neither any member of study site nor the study monitor will have access to the randomization
code until the end of the study and data base is locked. Investigator will break the code only in
case of emergency. However, the investigator will notify the Ethics Committee within 24 hours
of breaking of the code. The date and the reason for unblinding must be recorded. In the event
the Investigator require to break the blind for an individual subject during the study, the
investigator will unseal the envelope and break the blind for that subject only.
11.6.5 Baseline Definition
Visit 1 (Day 1) will be considered as the baseline visit. In case the Visit 1 (Day 1) value is
missing, Baseline assessment will be considered as the last non-missing assessment prior to the
start of study medication.

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11.6.6 Missing Data

Missing data will be treated as missing, and no imputation will be done.
11.6.7 Summary of Subject Disposition
An overall summary of subject disposition will be presented using number and percentage
(wherever applicable) for subjects screened, number enrolled, subjects who completed study
and subjects who discontinued, along with the reason of discontinuation. Summary of screen
failures will be presented. Number of subjects in each analysis population will be summarized.
Subject disposition summary will be presented by treatment as well as overall.
11.6.8 Demographics, Baseline Characteristics and Medical History
Continuous variables that are Age, weight, BMI, and other demographical characteristics will
be summarized by overall using summary statistics i.e., the number of observations, mean and
standard deviation with 95% CI (among normal distribution) or median with range (if non-
normal distribution). Categorical values like gender and clinical Examination will also be
summarized using frequencies and percentages. The medical history and Physical examination
will be presented using frequencies and percentages of subjects for the Safety population. For
continuous data student t test and for categorical data Chi square test will be estimated to
compare the baseline demographical data between groups and changes if any during the follow
up.
11.6.9 Treatments compliance
Subjects taking 80-120% of the planned study medications will be considered as compliant.
11.6.10 Efficacy and Safety Analysis
Primary Efficacy and secondary endpoints will be analyzed for the ITT and PP population both.
The results based on the ITT population will be considered as primary and the results based on
the PP population will be considered as supportive.
Incidence and rate of adverse events.
AEs and SEs will be summaries counting both the number of separate events and the number
of subjects experiencing events occurring during the study period will be provided overall, per
system organ class and preferred term by presenting. Furthermore, similar summaries will be
provided stratified according to the seriousness, severity, and relationship to the study
medication. The percentage of cases with an event will be analyzed and compared by the Chi-
Square test.
12. DOCUMENTATION
12.1 Supplementary Documentation
The final report will include a copy of protocol and its amendment (if any), EC approvals,
sample of informed consent form, case report form and completed CRFs.

12.2 Quality Assurance Audits

CRO will perform quality control and quality assurance on the protocol, conduct of the study
and clinical study report, in accordance with its SOPs. The raw data generated during the study,
including the clinical operations and the final reports will be liable to the inspection and quality
audit for conformance to this protocol and all the governing SOPs by an auditor from CRO.
12.3 Accessibility
Accessibility of the raw data will be limited to the EC, Sponsor, CRO and the regulatory
agencies for scheduled inspection and audits.

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 Protocol #: Galactagogue-1089-2024-01
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12.4 Confidentiality of Data

The data identifying study Subject’s name will be kept confidential and will be accessible only
to concerned study personnel, Quality assurance, Sponsor, and its authorized representatives
and, if necessary, EC and regulatory agencies.
12.5 Archives
Electronic copies and/or the paper copies of the entire raw data (including, forms filled in the
clinical sections, medical screening records generated during the study along with a copy of
the protocol and its amendment, CRF, informed consent form, audit reports, Ethics committee
correspondence, recruitment advertisements, research agreements and other relevant general
correspondence with the Sponsor) will be archived at the study site(s) for at least 2 years after
completion of the study or at least 2 years have elapsed since the formal discontinuation of
clinical development of the investigational product. Copy of the protocol and its amendment
along with informed consent form will be archived at CRO also. It is the responsibility of the
Sponsor to inform the CRO as to when these documents no longer need to be retained. The
investigator will promptly notify the CRO in the event of accidental loss or destruction of any
study records.
12.6 Publication Policy
Publication of the results of the study whether in whole or in part, shall be within the sole and
absolute discretion of the Sponsor.

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

13. ANNEXURES
Annexure 1: Case Record Form (CRF)
Annexure 2: Informed Consent Document (ICD)
Annexure 3: Product profile: Galact granules
Annexure 4: FDA license: Galact granules
Annexure 5: Declaration of Helsinki (WMA)
Annexure 6: Draft CTA
Annexure 7: Draft CTRI
Annexure 8: Self‐reported insufficient milk (SRIM) assessment by mother
Annexure 9: Subject Diary – Medication compliance

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

Annexure 10: Expression (automatic) of breast milk: Procedure

Milk volume will be measured after expression of breast milk from both breasts using a breast pump.
Device to be used:
LuvLap Electric Breast Pump with 3 Phase Pumping:
Massage
Stimulation
Expression
Rechargeable Battery
Manual Convertible Kit
Soft & Gentle
BPA Free

In case of any difficulty in using the breast pump, manual

method can be used for milk extraction.
Procedure to hand express breast milk: Instructions for mother(9)
Expressing breast milk by hand is a skill. Just like any other skill, it may take time to learn how to do it properly.
Practice the technique to get the best results.
You can follow these steps to express breast milk by hand. Remember to have a storage bottle, cup, or bowl ready.
Wash your hands with soap and water.
Get into a comfortable position and try to relax. You can place a warm towel on your breasts or gently massage
your breasts for a few minutes before you begin to help get the breast milk flowing.
Use a photo of your baby. Your baby could also be nearby; if not, that’s when it’s helpful to have a photo, a sound
recording of your child making sounds, or a blanket with your baby's scent, or try other relaxation techniques like
music to help stimulate your let-down reflex.(10)
Position your hand on your breast in the C-hold. That is, place your thumb on the top of your breast and your
fingers underneath your breast so that your hand is in the shape of a C.(11) Your thumb and your fingers should
be 1 to 2 inches behind your nipple.
Hold a clean collection cup or breast milk storage bottle under your breast with your other hand so that your nipple
is directly above it.
Begin to gently push your breast back toward your body with your thumb and fingers.
Bring your thumb and fingers together. Then, use a rolling motion as you move your hand forward toward your
original starting position. The gentle rolling motion will move the breast milk out of the milk ducts. Use firm but
gentle pressure as your breast tissue is sensitive and can be bruised or damaged if you are too rough.
Lean forward a little bit to collect the breast milk that should be dripping or spraying out of your nipple. Be careful
to get the breast milk into your collection container without any of the milk touching your hands first.
Repeat steps 6 and 7 at a steady, rhythmic pace until there isn't any more breast milk coming out or until you have
alleviated the fullness of engorgement. If you intend to completely drain your breasts, rotate your hand to another
position around the nipple (C, U, backward C, upside-down U) to express from all areas of the breast and begin
the process again.
Switch breasts when the flow of breast milk stops.
Give your baby the milk you expressed right away or seal it in a breast milk collection bag or container and store
it to use later.
Pro’s of hand expression:

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

This is a natural method.

It cost you zero.
It does not require any machinery other than a collection jar.
It’s is easy to learn.
It will always available for your baby
By using hand l make your breasts more relaxed.
Con’s of hand expression:
You will have to practice how to express your breast milk manually so that you have to spend some time studying
how to use your hand.
You can use a breast pump faster and more powerful.
Some women have issues with expressing their hands and can’t get breast milk.
Demonstration of hand-expression of breast milk(12)
How to hand expression tutorial || breast pumping || hand express Video - (2017) - YouTube

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

Annexure 11: Hand expression of breast milk: FAQs

Can you express breast milk by hand?

Expressing breast milk by hand before pumping might produce more milk than pumping alone. It can help improve
your supply of milk for your baby when they suck (5). Becoming more comfortable with your breasts while hand
expressing will also alert you to any changes which might need medical attention.
When to use breast massage and hand expression?
Breast massage and hand expression can be used at the beginning to get your milk flowing. Breast massage while
pumping increases the amount of milk you can express. Continuing to hand express can release milk remaining,
even after the pump flow has stopped. And if your pump breaks down, or there is no electricity, you always have
your hands.
How do you express both breasts at the same time?
You can use either or both hands on one breast, or express both breasts at the same time. Hold your hand in the
shape of a letter ‘C’, with your thumb and forefinger behind the base of your nipple, feeling for the change in texture
of your breast. Move your fingers closer to, or away from your nipple to find the best place for you.
What is the purpose of using milk expression by hand?
If you are pregnant or breastfeeding, milk expression by hand is a useful technique to learn. It’s a handy way to
relieve engorged breasts. You can also use it to stimulate milk production and provide milk for a baby who is not
breastfeeding well or needs more milk.

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 Protocol #: Galactagogue-1089-2024-01
Version 1; dt. 12th February 2024

14. REFERENCES

1
Romano M, Cacciatore A, Giordano R, La Rosa B. Postpartum period: three distinct but continuous
phases. J Prenat Med. 2010 Apr;4(2):22-5. PMID: 22439056; PMCID: PMC3279173.
2
Lee S, Kelleher SL. Biological underpinnings of breastfeeding challenges: the role of genetics, diet,
and environment on lactation physiology. Am J Physiol Endocrinol Metab. 2016 Aug
1;311(2):E405-22. doi: 10.1152/ajpendo.00495.2015. Epub 2016 Jun 28. PMID: 27354238;
PMCID: PMC5005964.
3
Javan R, Javadi B, Feyzabadi Z. Breastfeeding: A Review of Its Physiology and Galactogogue Plants
in View of Traditional Persian Medicine. Breastfeed Med. 2017 Sep;12(7):401-409. doi:
10.1089/bfm.2017.0038. Epub 2017 Jul 17. PMID: 28714737.
4
Gupta M, Shaw B. A Double-Blind Randomized Clinical Trial for Evaluation of Galactogogue
Activity of Asparagus racemosus Willd. Iran J Pharm Res. 2011 Winter;10(1):167-72. PMID:
24363697; PMCID: PMC3869575.
5
Alok S, Jain SK, Verma A, Kumar M, Mahor A, Sabharwal M. Plant profile, phytochemistry and
pharmacology of Asparagus racemosus (Shatavari): A review. Asian Pac J Trop Dis. 2013
Jun;3(3):242–51. doi: 10.1016/S2222-1808(13)60049-3. PMCID: PMC4027291.
6
Saleem M, Martin H, Coates P. Prolactin Biology and Laboratory Measurement: An Update on
Physiology and Current Analytical Issues. Clin Biochem Rev. 2018 Feb;39(1):3-16. PMID:
30072818; PMCID: PMC6069739.
7
Parihar, Shweta & Sharma, Devender. (2021). A BREIF OVERVIEW ON ASPARAGUS
RACEMOUS. 8. 959-975.
8
Birla A, Satia M, Shah R, Pai A, Srivastava S, Langade D. Postpartum Use of Shavari Bar ® Improves
Breast Milk Output: A Double-Blind, Prospective, Randomized, Controlled Clinical Study.
Cureus. 2022 Jul 13;14(7):e26831. doi: 10.7759/cureus.26831. PMID: 35974870; PMCID:
PMC9375125.
9
Whipps, M. D., & Demirci, J. R. (2021). The sleeper effect of perceived insufficient milk supply in
US mothers. Public Health Nutrition, 24(5), 935–941.
https://doi.org/10.1017/S1368980020001482.

Confidential Page 34 of 34
Patient Initials: |__|__|__| Randomization No: |__|__|__| `Protocol No.: Galactagogure-1089-2024-01
Date: |__|__|/|__|__|/|__|__|

Patient No. __________

CASE RECORD FORM (CRF)

Study Title
Evaluation of Efficacy and Safety of Galact® Granules
(Shatavari Formulation) as a Galactagogue in Post-
partum Women: A Prospective, Randomized, Double-
blind, Placebo-Controlled Study

Protocol No.: Galactagogure-1089-2024-01

Version 1; dt. 13th February 2024

Clinical Study
Patient Initials: |__|__|__|

Patient screening no.: |__|__|__| Randomisation no.: |__|__|__|

(Enter Patient Initials as three characters, If patient has only 2 Initials, enter dash (-) in the middle box)

Investigator’s Name: …………………………………………………………………………...

Page 1 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| `Protocol No.: Galactagogure-1089-2024-01
Date:
|__|__|/|__|__|/|__|__|

INSTRUCTIONS

1. PLEASE ENTER THE PATIENT NO. AND INITIALS ON EACH PAGE OF THE
CASE RECORD FORM (CRF).
2. PLEASE TRY TO COMPLETE THE CRF AND DO NOT LEAVE ANY BLANK
SPACES.
3. OPEN BRACKETS AND DOTTED LINES ARE FOR ENTRY OF NUMBERS
AND TEXT AND CLOSED BOXES ARE FOR TICK-MARK.
4. PLEASE TICK () IN THE APPROPRIATE BOXES.
4. IF DATA IS NOT AVAILABLE OR NOT APPLICABLE, PLEASE ENTER N.A.
OR IF NOT DONE, ENTER N.D.
4. FOR CORRECTION OF ANY ENTRIES, STRIKE OUT THE INCORRECT
ANSWER AND ENTER THE CORRECT ENTRY ALONGSIDE, INITIAL AND
DATE IT. DO NOT RUB, ERASE OR USE CORRECTION FLUID, FOR
INCORRECT ENTRIES.
5. PLEASE ENTER ALL DATA WITH A DARK BLUE OR BLACK BALL-POINT
PEN.
6. USE ONLY STANDARD ABBREVIATIONS, IF REQUIRED.
7. USE DATE FORMAT AS DD / MM / YYYY

Page 2 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 1: Screening /Baseline: Day-1
Date: |__|__|/|__|__|/|__|__|

INCLUSION CRITERIA
Please check all statements and tick (√) the appropriate box

Yes No

1. Healthy women between 20-45 years of age  

2. Women with uncomplicated full-term delivery (vaginal or LSCS).  

3. Women who have accomplished antenatal breastfeeding promotion  

protocol immediately post-partum or within three days of delivery.

4. Women able to understand the study requirements and follow other  

procedures required by the study protocol.

5. Must have the ability and willingness to sign an informed consent and to  
comply with all study procedures.

Page 3 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 1: Screening /Baseline: Day-1
Date: |__|__|/|__|__|/|__|__|

EXCLUSION CRITERIA
Please check all statements and tick (√) the appropriate box.

Yes No
1. Post-partum women with contraindications to breastfeeding, such as HIV,
chemotherapeutic drugs, radioactive substances, and babies with  
galactosemia.
2. Post-partum women with unstable conditions (i.e., post-partum  
haemorrhage, sepsis).
3. Women with known allergies to Shatavari or oats, raisins, almonds, cocoa,  
and honey.
4. Women already using products that have galactagogue properties.  
5. Women whose babies require phototherapy, women with insufficient
glandular tissue or breast surgery and any structural abnormality of the  
breast.
6. Women with a history of infertility, hypothyroidism, women with twins, or  
higher-order births.
7. Any known clinically significant endocrine, metabolic, hepatic, renal,
cardiovascular, gastrointestinal, respiratory, hematological, or neurological  
illnesses or the presence of any current psychiatric disorders in women will
be considered as exclusion criteria.
8. If any other investigational drug was used within three months before the
entry in this study or those who cannot be relied upon to comply with the  
test procedures or are unwilling to give informed consent will be excluded.

Page 4 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 1: Baseline: Day-1
Date: |__|__|/|__|__|/|__|__|

VISIT 1: (BASELINE VISIT: DAY 1)

INFORMED CONSENT PROCESS

Informed consent:  Yes  No

Date of Consent: |__| |__| / |__||__| / |__| |__| Time of consent: |__| |__|: |__| |__| hrs. (24 hr.)

DEMOGRAPHY& MEDICAL HISTORY

Patient Initials: |__||__| |__| Patient Screening No: |__| |__| |__|
Age: |__| |__| yrs.

Height: |__| |__| |__| cm. Weight: |__| |__| |__| Kg.

Medical History:  Yes  No

If yes: ___________________________________________________________________

PHYSICAL EXAMINATION AND VITAL SIGNS

Parameter Results

Systolic Blood Pressure (mm Hg) |__| |__| |__|

Diastolic Blood Pressure (mm Hg) |__| |__| |__|
Pulse Rate (per min.) |__| |__| |__|
Body Temperature (0F) |__| |__| |__| . |__|
Respiratory Rate (per min.) |__| |__|
BMI (kg/sq.m2) |__| |__| . |__|

LABORATORY ASSESSMENT

Date of Sample collection: |___||___|/|___||___|/|___||___| Time: |___||___|:|___||___|hrs.

Test Result Units
Serum Prolactin |___| |___| |___| |___| |___| (ng/mL)

Physicochemical parameters

Total. protein |___| .|___| |___| (g/L)

Albumin |___| .|___| |___| (g/L)

Globulin |___| .|___| |___| (g/L)

Sp. gravity |___| .|___| |___| |___| (°C)

Page 5 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 1: Baseline: Day-1
Date: |__|__|/|__|__|/|__|__|

STUDY MEDICATION DISPENSING

Does the patient satisfy Inclusion/Exclusion criteria & is enrolled in the study?

 Yes  No
If Yes, Randomization no. |__| |__| |__|
Date of visit: |__| |__|/ |__| |__|/|__| |__||__| |__|

Capsules Issued on the visit:  Yes  No

CONCOMITANT MEDICATION

 Yes  No
(If yes, please specify below)

Date Name of drug Dose Start date Stop date Reason

(Generic name) /ongoing

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----
---/----/---- ---/----/---- ---/----/----
---/----/---- ---/----/---- ---/----/----
---/----/---- ---/----/---- ---/----/----

BASELINE ADVERSE EVENTS (AE)

Did the patient experience any of the following Adverse Events (AE)?  Yes  No
(Please tick () in the appropriate column and fill the AE form on last page if answer is present)
Adverse event Date Severity
Time Mild Moderate Severe

Page 6 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 3: (Week 4 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

VISIT 2: (DAY 3- 72 HOURS AFTER DELIVERY)

PHYSICAL EXAMINATION

Parameter Results
Systolic Blood Pressure (mm Hg) |__| |__| |__|
Diastolic Blood Pressure (mm Hg) |__| |__| |__|
Pulse Rate (per min.) |__| |__| |__|
Body Temperature (0F) |__| |__| |__| . |__|
Respiratory Rate (per min.) |__| |__|
BMI (kg/sq.m2) |__| |__| . |__|

TIME TO NOTICEABLE BREAST FULLNESS

Date of delivery : |__| |__| / |__||__| / |__| |__| Time: |__| |__|: |__| |__| hrs.

Date of noticeable breast fullness: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs.

BREAST MILK VOLUME MEASUREMENT

Measurement by breast pump:  Manual  Automatic

Breast milk collection: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs. (24 hr.)

Total milk volume expressed: |__||__|. |__| ml

INFANT WEIGHT MEASUREMENT

Infant weight after delivery: |__|. |__| |__| kg

SUBJECTIVE ASSESSMENT FOR BREAST FULLNESS

Please tick (√) the appropriate box

Questions Very Satisfied Neutral Unsatisfied Very

satisfied unsatisfied

Subjective satisfaction of mother 0 1 2 3 4

1. For the well-being and happiness of
babies, and regarding state of
    
lactation

2. For the taste and ease of use of the

product
    

Page 7 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 3: (Week 4 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

CONCOMITANT MEDICATION

 Yes  No
(If yes, please specify below)

Date Name of drug Dose Start date Stop date Reason

(Generic name) /ongoing
---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

Page 8 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 3: (Week 4 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

VISIT 3: (WEEK 4 ± 4 DAYS)

PHYSICAL EXAMINATION
Parameter Results

Systolic Blood Pressure (mm Hg) |__| |__| |__|

Diastolic Blood Pressure (mm Hg) |__| |__| |__|

Pulse Rate (per min.) |__| |__| |__|

Body Temperature (0F) |__| |__| |__| . |__|
Respiratory Rate (per min.) |__| |__|
BMI (kg/sq.m2) |__| |__| . |__|

TIME TO NOTICEABLE BREAST FULLNESS

Noticeable breast fullness date: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs. (24 hr.)

BREAST MILK VOLUME MEASUREMENT

Measurement by breast pump  Manual  Automatic

Breast milk collection: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs. (24 hr.)

Total milk volume expressed: |__||__|. |__| ml

LABORATORY ASSESSMENT

Date of Sample collection: |___||___|/|___||___|/|___||___| Time: |___||___|:|___||___|hrs.

Test Result Units

Serum Prolactin |___| |___| |___| |___| |___| (ng/mL)

Physicochemical parameters

Total. protein |___| .|___| |___| (g/L)

Albumin |___| .|___| |___| (g/L)

Globulin |___| .|___| |___| (g/L)

Sp. gravity |___| .|___| |___| |___| (°C)

Page 9 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 3: (Week 4 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

SUBJECTIVE ASSESSMENT FOR BREAST FULLNESS

Please tick (√) the appropriate box

Questions Very Satisfied Neutral Unsatisfied Very

satisfied unsatisfied

Subjective satisfaction of mother 0 1 2 3 4

1. For the well-being and happiness of
babies, and regarding state of
    
lactation

2. For the taste and ease of use of the

product
    

SELF‐REPORTED INSUFFICIENT MILK (SRIM) ASSESSMENT BY MOTHER

Questions Not Very
important important
at all
1 2 3 4
1. Breast milk alone did not satisfy baby.
   
2. The baby was not gaining enough weight.
   
3. A health professional said the baby was not
gaining enough.
   
4. Mom had trouble getting the milk flow to start.
   
5. Mom did not have enough milk.
   
INFANT WEIGHT MEASUREMENT
Infant weight: |__|. |__| |__| kg

EPISODES OF ILLNESS IN INFANTS SINCE LAST VISIT

No. of episodes
Sr Infective episodes Yes No
Period since previous visit
1. Respiratory infections   |__||__|
2. Gastrointestinal   |__||__|
3. Febrile episodes   |__||__|

NEED FOR INFANT FORMULA FEED

Yes  No 

If yes, specify: ………………………………………………………………………………………………………

Page 10 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 3: (Week 4 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

CONCOMITANT MEDICATION

 Yes  No
(If yes, please specify below)

Date Name of drug Dose Start date Stop date Reason

(Generic name) /ongoing
---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

ADVERSE EVENTS (AE)

Did the patient experience any of the following Adverse Events (AE)?

 Yes  No
(Please tick () in the appropriate column and fill the AE form on last page if answer is present)
Adverse event Date Severity
Time Mild Moderate Severe

SERIOUS ADVERSE EVENTS (SAE)

Did the patient experience any Serious Adverse Events (SAE)?

 Yes  No
(If yes, please fill the SAE form last page)

Page 11 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

VISIT 4: (WEEK 16 ± 4 DAYS)

PHYSICAL EXAMINATION
Parameter Results

Systolic Blood Pressure (mm Hg) |__| |__| |__|

Diastolic Blood Pressure (mm Hg) |__| |__| |__|

Pulse Rate (per min.) |__| |__| |__|

Body Temperature (0F) |__| |__| |__| . |__|
Respiratory Rate (per min.) |__| |__|
BMI (kg/sq.m2) |__| |__| . |__|

TIME TO NOTICEABLE BREAST FULLNESS

Noticeable breast fullness date: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs. (24 hr.)

BREAST MILK VOLUME MEASUREMENT

Measurement by breast pump  Manual  Automatic

Breast milk collection: |__||__| / |__||__| / |__||__| Time: |__| |__|: |__| |__| hrs. (24 hr.)

Total milk volume expressed: |__||__|. |__| ml

INFANT WEIGHT MEASUREMENT

Infant weight after delivery: |__|. |__| kg
LABORATORY ASSESSMENT

Date of Sample collection: |___||___|/|___||___|/|___||___| Time: |___||___|:|___||___|hrs.

Test Result Units

Serum Prolactin |___| |___| |___| |___| |___| (ng/mL)

Physicochemical parameters

Total. protein |___| .|___| |___| (g/L)

Albumin |___| .|___| |___| (g/L)

Globulin |___| .|___| |___| (g/L)

Sp. gravity |___| .|___| |___| |___| (°C)

Page 12 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

SUBJECTIVE ASSESSMENT FOR BREAST FULLNESS

Please tick (√) the appropriate box

Questions Very Satisfied Neutral Unsatisfied Very

satisfied unsatisfied

Subjective satisfaction of mother 0 1 2 3 4

1. For the well-being and happiness
of babies, and regarding state of
    
lactation

2. For the taste and ease of use of the

product
    

SELF‐REPORTED INSUFFICIENT MILK (SRIM) ASSESSMENT BY MOTHER

Questions Not Very
important important
at all
1 2 3 4
1. Breast milk alone did not satisfy baby.
   
2. The baby was not gaining enough weight.
   
3. A health professional said the baby was not
gaining enough.
   
4. Mom had trouble getting the milk flow to start.
   
5. Mom did not have enough milk.
   
INFANT WEIGHT MEASUREMENT
Infant: |__|. |__| |__| kg

EPISODES OF ILLNESS IN INFANTS SINCE LAST VISIT

No. of episodes
Sr Infective episodes Yes No
Period since previous visit
1. Respiratory infections   |__||__|
2. Gastrointestinal   |__||__|
3. Febrile episodes   |__||__|

NEED FOR INFANT FORMULA FEED

Yes  No 

If yes, specify: ………………………………………………………………………………………………………

Page 13 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

COMPLIANCE ASSESSMENT
Please tick (√) the appropriate box
Medication Issued/ Return Record Form
Capsules
Visit Date Issued on this visit Returned Compliance1
4
 Yes  No  Compliant  non-compliant
CONCOMITANT MEDICATION

 Yes  No
(If yes, please specify below)

Date Name of drug Dose Start date Stop date Reason

(Generic name) /ongoing
---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

---/----/---- ---/----/---- ---/----/----

ADVERSE EVENTS (AE)

Did the patient experience any of the following Adverse Events (AE)?  Yes  No
(Please tick () in the appropriate column and fill the AE form on last page if answer is present)
Adverse event Date Severity
Time Mild Moderate Severe

1Compliant: If ≥ 80% of medication consumed according to prescribed regimen.

Non-compliant: If < 80% of study medication consumed/applied according to prescribed regimen
Compliance will be assessed as per formula:
Compliance (%)= Capsule taken till patient visit date / Capsules supposed to be taken till visit date X 100

Page 14 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

SERIOUS ADVERSE EVENTS (SAE)

Did the patient experience any Serious Adverse Events (SAE)?  Yes  No
(If yes, please fill the SAE form last page)

STUDY COMPLETION/TERMINATION

Patients did complete the entire study.  Yes  No

Page 15 of 18 Investigator’s Signature

 Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

ADVERSE EVENT (AE) PAGE (Contd.)

Record all adverse events regardless of suspected causality to study treatment.
Specify diagnosis, not individual symptoms, if possible.

 No Adverse Event

Please enter individual ‘event’ in separate column

ADVERSE EVENT ➔

DATE OF ONSET ____/____/____ ____/____/____

SEVERITY
(Check one only)  Mild  Moderate  Severe  Mild  Moderate  Severe
ACTION - (check all relevant)
▪ Study Drug Dose was:  Increased  Increased
 Reduced  Reduced
 Stopped Temporarily  Stopped Temporarily
 Permanently Discontinued  Permanently Discontinued
▪ Treatment given:  Give details in Associated  Give details in Associated
Illness & Medication Table Illness & Medication Table
▪ Other (specify): _______________________  ______________________
▪ No action  
SERIOUSNESS OF AE  Yes  No  Yes  No
(See seriousness criteria) If yes, notify sponsor/CRO If yes, notify sponsor/ CRO
immediately immediately
OUTCOME OF AE TO DATE  Yes  Unknown  Yes  Unknown
Still Present?
 No - Resolved on  No - Resolved on
Date: ____/____/____ Date: ____/____/____

CAUSALITY
In the doctor’s judgement, was  Yes  No  Yes  No
study treatment the most likely
cause of the AE?
If No, what was the most likely
cause of the AE? (Check one only)
 ______________  ______________
▪ Disease Under Study

 ______________  ______________
▪ Other Illness (specify)

 ______________  ______________
▪ Concomitant Treatment
(specify)
▪ Other (specify)  ______________  ______________

Page 16 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

SERIOUS ADVERSE EVENT FORM

Study Center: Doctor: Doctor No.:
Patient Patient Date of Birth: Age Sex Height Weight Onset of event End of event
Initials: Number:

Tick all appropriate to adverse event

Life Threatening Congenital anomaly Significant Hazard
Required / prolonged hospitalization Overdose Patient died on
Permanently disabling Cancer Date:
Describe event (signs, symptoms, sequence of events, relevant tests, laboratory data, treatment of event, residual effect).
Continue on a separate page if required and attach copies of relevant documents.

Relevant medical history (e.g., previous diagnosis, surgery, allergy, pregnancy).

Drug given Daily Dose Indication Therapy dates

________________ __________ ________________________
From ______
To ______
Route of administration Did event abate after Did event recur after Causal relationship to event
stopping drug? reintroduction?
None Possible
Yes No NA Yes No NA

Concomitant drug(s) [Exclude those used to treat the event; use second form in case of more than 5 drugs]
Drug Daily Route of Indication Therapy dates Causal relationship to event
Dose administrati from to
on
None Possible
None Possible
None Possible
None Possible
None Possible
Report type Date of this report Reporting Doctor's name & address Doctor's signature
Initial
Final

DO NOT FILL IN THE AREA BELOW

Serious Yes No Comments
Unexpected Yes No
Associated with Study drug Yes No
Date Received Name Of Medical Monitor Signature

Page 17 of 18 Investigator’s Signature

Patient Initials: |__|__|__| Randomization No: |__|__|__| Visit 4: (Week 16 ± 4 Days)
Date:|__|__|/|__|__|/|__|__|

END OF STUDY INFORMATION

Did the patient complete the entire study: No  Complete section A, B

Yes  Complete Section B

Section A

To be completed only for patients prematurely terminated. Primary reasons for premature termination:

Adverse Event Death

Patient non-compliance Protocol violation

Consent withdrawn Cured

Insufficient therapeutic effect Other

Patient lost to follow up Specify: ______________________________

Section B

To be completed for all patients

Please check that all pages of this form are complete

Demography and medical history, concomitant medication, Adverse events

Questionnaire: Breast milk volume measurement, Time to noticeable breast fullness,

Infant weight measurement. Laboratory assessment, Subjective assessment for breast fullness
SRIM, Episodes of illness in infants, Need for infant formula feed

I certify that the entries on all the pages of the case report form, accurately and completely represent
the results of examinations, tests, and evaluations performed on the dates specified.

Date: ___/___/___

Principal Investigators signature ______________________________

Page 18 of 18 Investigator’s Signature

Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

Participant Information Sheet (PIS)

Protocol Title : Evaluation of Efficacy and Safety of Galact Granules (Shatavari

Formulation) as a Galactagogue in Post-partum Women: A
Prospective, Randomized, Double-blind, Placebo-Controlled Study
Study Code : Galactagogure-1089-2024-01; Version 1; dt. 12th February 2024
Name of the Patient : ______________________________________
Doctor’s Name : Dr. Ashvini Deshmukh
Hospital Name : Associate Professor,
Department of Obstetrics and Gynecology,
DY Patil Medical College and Hospital,
Nerul, Navi Mumbai 400706, Maharashtra.
Sponsor’s Name : Emcure Pharmaceuticals Ltd., India.
Sponsor’s Address : Emcure Pharmaceuticals Ltd.,
Oberoi Garden Estates, Yadav Nagar,
Chandivali, Powai, Mumbai 400072, Maharashtra.

1. Introduction:
The postpartum period begins soon after the delivery of the baby and usually lasts six to eight
weeks and ends when the mother's body has nearly returned to its pre-pregnant state.
Lactogenesis (milk production) is a complex neurophysiological process that involves the
action of a number of hormones, mainly prolactin. Prolactin is secreted by the anterior pituitary
gland in response to nipple stimulation. During the first six months of life, breast milk is the
optimal source of nutrition for babies. The most common cause of breastfeeding failure is
insufficient production of breast milk which is also known as lactational inadequacy.
Galactagogue medicines, such as metoclopramide, oxytocin, domperidone, chlorpromazine
and sulpiride, are among the current therapeutic strategies in healthy mothers. However, these
medications are associated with adverse effects, such as extrapyramidal symptoms, arrhythmia,
and iatrogenic hyperthyroidism in mother or infant. Therefore, alternative therapies have been
under investigation. Herbal medications have shown the potential for safe and effective
treatment for milk production in post-partum women. Shatavari is known as the “Queen of
Ayurvedic herbs”. It has a long history of use as a galactagogue in India and is also included
in the official ayurvedic pharmacopeia for this use. It is loaded with folic acid, vitamins A, C,
and K, and phytoestrogens; the hormonal effect of phytoestrogens is like estrogen in milk
production. A key regulator of prolactin production is estrogens which enhance the growth of
prolactin-producing cells and stimulate prolactin production directly, as well as by suppressing
dopamine. It also contains tryptophan, an essential amino acid that may stimulate prolactin
production, leading to increased milk production.
Shatavari is commonly available in the form of tablets, capsules, or powder. So far, studies
including randomized controlled trials support the use of shatavari as a galactagogue for 4-6
weeks. However, long term efficacy of shatavari for this indication has not been explored yet.
This study aims to investigate the potential benefits of Galact Granules (Shatavari Formulation)
as a Galactagogue in post-partum woman for milk production.

1
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

2. Purpose of the trial:

The clinical research study in which your participation is proposed aims to evaluate the efficacy
and safety of Galact Granules (Shatavari Formulation) as a Galactagogue in Post-partum
Women: A Prospective, Randomized, Double-blind, Placebo-Controlled Study.
Prospective means that you would be given therapy, and we would observe the effects of
therapy after starting the study therapy.
Randomized means that you would be given therapy in a random manner, i.e., you may receive
either ‘Galact granules powder’ or ‘Identical protein/placebo powder’ during the entire study
period.
Double-blind means that both you and your attending doctor will not be aware of the treatment
received by you. This type of blinding helps us reduce bias and error in the results of the study.
Placebo means that the powder will not contain shatavari but some other inactive substance.
By using the placebo, we come to know whether the positive results are because of shatavari
or are because of psychological factors.
Placebo-controlled means that we compare the results of ‘Galact therapy’ or ‘Placebo therapy’.
Thus, the placebo here acts like a control or a reference with which Galact granules is
compared.
It is expected that you will benefit from this medicine. On agreeing to participate in this study,
you hereby willfully agree to undertake the study activities and medication schedule as required
by the study.
The knowledge gained from this study would be of benefit to many thousands of patients who,
like you, may suffer from this kind of medical condition.
3. Procedure to be followed:
In this study, a total of 110 subjects will be enrolled. At the initial visit, prospective subjects
would be screened for enrollment based on the requirements of the study, history, and clinical
examination. Before starting any study-related procedures, you would be explained about the
study in detail and written informed consent would be obtained from you to participate in this
study. This document is a part of the written informed consent procedure.
A detailed medical history including the associated conditions will be recorded. A general and
physical examination would be done to see any abnormal parameters. If you satisfy the
eligibility criteria, you will be enrolled in the study.
After enrollment in the study, you will be asked to consume 2 teaspoons powder of Galact
granules (containing Shatavari (Asparagus racemosus) 15 g, Vidari Kand (Pueraria tuberose)
1 g , Sowa (Anethum Sowa) 1 g, Gokhru Panchang (Tribulus terrestris) 2.5 g, Yashtimadhu
(Glycyrrhiza glabra) 1 g, Jeera (Safed) (Cuminum cyminum) 1 g, Ahliv powder (Lepidium
sativum) 1 g, with Elaichi flavor) or placebo/reference product (containing protein mixture
without contents of Galact granules.) twice daily with one glass of milk for 16 weeks.
You will be monitored throughout the study. After the initial Visit 1 (screening,
baseline/randomization) (Day 1), you will have to visit the clinic for assessment at visit 2
follow-up (day 3- 72 hours after delivery), visit 3 follow-up (week 4), and visit 4 end of study
(week 16). Blood sample will be collected for prolactin hormone level and Breast milk sample
will be collected for quality check on Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit-
Day 1), Visit 3 (Week 4), and Visit 4 (Week 16). Subjective assessment for breast fullness and
Self‐reported insufficient milk (SRIM) assessment by mother assessments would be done. Side

2
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

effects will be monitored during each visit of the study period. The study will be completed in
16 weeks.
4. Potential Risks of participating in the study
As with all new and old medicines there may be some unforeseen risks associated with this
treatment. Care has been taken to design the study to minimize any possible harm, with
appropriate screening tests and examinations by the doctor.
The doctor in-charge / attending doctor of the study would explain all other risks associated
with the study medication to you.
The efficacy and safety of shatavari has been well established and it has been used since ancient
times of ayurveda. Hence, it is unlikely that you may experience any side effects with the study
treatment in the dose that you would take in the study.
5. Benefits of the study:
The study therapy may benefit you for improving breast milk quantity and quality as well. It is
therefore possible that it may improve your symptoms as well. The study medication would be
provided free of cost to you by the Sponsor. However, no compensation will be given to you
for travelling to the study clinic / hospital and loss of wages / income because of your visit to
the clinic.
The knowledge gained from this study would be of benefit to many thousands of women in
their post-partum period.
6. Alternative treatments:
Milk production can be increased by relaxation techniques and psychological support, many
mothers tend to use medications or other products to increase their lactation.
7. Confidentiality of the record:
Your medical records that are related to this trial will be maintained in confidentiality. The
medical monitor and quality assurance representatives from Sponsor (Emcure Pharmaceuticals
Ltd., India.) may examine your medical records if your name cannot be identified from these
records.
Your records from this trial may be submitted by the Sponsor to the Government Authorities
who control the drugs in the state and the country, but your name will not be identified from
such records. No identity of any specific patient in this trial will be disclosed in any public
reports or publications.
The authority has the right upon proper judicial order to review pertinent medical records and
other data with your name identified. They are required by law; however, the information will
be handled in a confidential manner.
8. Your Participation in the Study and your Rights
Your participation in this study is voluntary and you may withdraw from the study at any time
without having to give reasons for the same. In any case, you will be given proper treatment
for your condition. Your refusal to participate will not involve any penalty in terms of
subsequent participation in research studies. You will agree to cooperate fully with the
attending doctor.
If at any time you feel worse or suffer any other illnesses, then please inform your attending
doctor. If the treatment appears to be unsuitable for you it will be stopped. It is possible that
the study could be stopped without your consent. Your doctor will tell you if any new

3
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

information becomes known during the study, which may affect your willingness to continue
in the study.
If you suffer from any treatment-related injury during the study, the Sponsor will pay the
medical expenses for the treatment of that injury. No other compensation is available from the
Sponsor.
9. If you have any queries related to the drug information and safety, you can contact
the medical monitor of the study.
Name : Dr Prajakta Wangikar, PhD
Address : Manager, Medical Services,
Emcure Pharmaceuticals Ltd.,
Oberoi Garden Estates, Yadav Nagar,
Chandivali, Powai, Mumbai 400072, Maharashtra.
Telephone : +91 97698 51047
E mail : [email protected]
10. If any problem develops, you can contact the investigator.
If any serious problems develop, you will receive prompt and appropriate medical attention. It
is agreed that the facilities of the above-mentioned hospital will be made available to you.
Reasonable medical treatment will be free when provided through the above-mentioned
hospital.
Financial compensation is not available for medical treatment elsewhere, loss of work, or other
expenses.
11. If you have any queries related to ethical issues & your rights, you can contact the
following from IEC Faculty.
Dr. Dnyanesh Belekar
Chairman IEC,
IEC for Biomedical and Health Care Research
D Y Patil Medical College & Hospital, Navi Mumbai
E-mail: [email protected]
Contact: 80822 88852
12. Financial consideration:
As part of our commitment to ensuring your protection, EmCure will provide insurance
coverage for any research-related injuries or unforeseen events that may occur during your
participation in this trial.
13. Obtaining additional information:
You are encouraged to ask any questions that occur to you at this time or to ask questions at
any time during your participation in the trial. You will be given a copy of this document for
your own information. If you desire more information later, you may call the investigator or
any member of the study team at the site.
14. Signature
I have read the above information and have had the opportunity to ask any questions and all
my questions have been answered.
I am also aware of my right to opt out of the trial at any time during trial without having to give

4
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

reason for doing so.

I have been given a copy of the information sheet & consent form.

Name of Patient: _______________________________________________________

Signature/ Thumb impression: _______________________ Date: ___________

Impartial witness Name: _________________________________________________

Signature/ Thumb impression: _______________________ Date: ____________

I the undersigned have fully explained in local language the relevant details of this trial to the
patient named above and/or authorized to consent for the patient. I am qualified to perform this
role.
(In Case of Illiterate Pts)

Name of Investigator: ____________________________________________________

Signature: ____________________________________ Date: ____________

5
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
Study Code: Galactagogure-1089-2024-01 Informed Consent Document (ICD)
ICD-English, Version-1, dt. 15th February 2024 Patient Screening No: |__|__| − |__|__|__|

Informed Consent Form (ICF)

Protocol Title : Evaluation of Efficacy and Safety of Galact Granules (Shatavari

Formulation) as a Galactagogue in Post-partum Women: A
Prospective, Randomized, Double-blind, Placebo-Controlled Study
Study Code : Galactagogure-1089-2024-01; Version 1; dt. 12th February 2024
Patient Name : ____________________________________________________

Age:______ years or DOB ____ / ____ / ____

Patient Initials: ______

Patient
Sr.
Initials
I confirm that I have read and understood the information sheet for the above
1.
study and have had the opportunity to ask questions.
I understand that my participation in the study is voluntary and that I am free
2. to withdraw at any time, without giving any reason, without having any
medical or legal rights being affected.
I understand that the Sponsor of the clinical trial, others working on the
Sponsor’s behalf, the regulatory authorities will not need my permission to
look at my health records both in respect of the current study and any future
3.
research that may be conducted in relation to it, even if he/she withdraws from
the trial. I agree to this access. However, I understand that his/her identity will
not be revealed in any information released to third parties or published.
4. I agree not to restrict the use of any data or results that arise from this study.

5. I hereby agree to take part in the above study

I have been informed about the procedures and number of visits of the above
6.
referenced study in detail in Patient Information Sheet
I have been explained about the potential risks and benefits (in Patient
7.
Information Sheet).

Signature/Thumb impression of patient: ______________ Date: _______________

Sign of the investigator: ____________________________ Date: _______________

Signature of Impartial Witness: _____________________ Date: _______________

(In Case of Illiterate Pts)

6
Signature/thumb impression of patient/Impartial witness
(To be executed in duplicate and one copy handed over to the subject/patient)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

प्रतिभागी सूचना पत्र (पीआईएस)

प्रोटोकॉल शीर्षक : पोस्ट-पाटष म मतिलाओं में गैलेक्टागॉग के रूप में गैलेक्ट ग्रैन्यूल (शिावरी
फॉमूषलेशन) की प्रभावकाररिा और सुरक्षा का मूल्ांकन: एक संभातवि,
यादृच्छिक, डबल-ब्लाइं ड, प्लेसबो-तनयंतत्रि अध्ययन
अध्ययन कोड : गैलेक्टागोगुर-1089-2024-01; संस्करण 1; डीटी। 12 फरवरी 2024
रोगी का नाम : ______________________________________
डॉक्टर का नाम : डॉ. अचिनी दे शमुख
रुग्णालयािे नाव : एसोचसएट प्रोफेसर,
प्रसूचत एवं स्त्री रोग चवभाग,
डीवाई पाचटल मेचडकल कॉलेज और अस्पताल,
नेरुल, नवी मुंबई 400706, महाराष्ट्र।
प्रायोजक का नाम : एमक्योर फामाास्युचटकल्स चलचमटे ड, भारत।
प्रायोजक का पता: एमक्योर फामाास्युचटकल्स चलचमटे ड,
ओबेरॉय गाडा न एस्टे ट्स, यादव नगर,
िांदीवली, पवई, मुंबई 400072, महाराष्ट्र।
1. पररचय:
प्रसवोत्तर अवचि बच्चे की चडलीवरी के तुरंत बाद शुरू होती है और आमत र पर छह से आठ सप्ताह तक रहती
है और तब समाप्त होती है जब मां का शरीर लगभग अपनी पूवा -गभावती अवस्था में वापस आ जाता है।
लैक्टोजेनेचसस (दू ि उत्पादन) एक जचटल न्यूरोचफचज़योलॉचजकल प्रचिया है चजसमें कई हामोन, मुख्य रूप से
प्रोलैक्टक्टन की कारा वाई शाचमल है। प्रोलैक्टक्टन चनप्पल उत्तेजना के जवाब में पूवाकाल चपट्यूटरी ग्रंचथ द्वारा स्राचवत
होता है। जीवन के पहले छह महीनों के द रान, स्तन का दू ि चशशुओं के चलए पोषण का इष्ट्तम स्रोत है। स्तनपान
की चवफलता का सबसे आम कारण स्तन के दू ि का अपयााप्त उत्पादन है चजसे लैक्टेशनल अपयााप्तता के रूप में
भी जाना जाता है।
गैलेक्टागॉग दवाएं , जैसे मेटोक्लोप्रमाइड, ऑक्सीटोचसन, डोमपररडोन, क्लोरप्रोमाचज़न और सल्पीराइड, स्वस्थ
माताओं में वतामान चिचकत्सीय रणनीचतयों में से हैं। हालांचक, ये दवाएं प्रचतकूल प्रभावों से जुडी हैं, जैसे चक
एक्सटर ै चपराचमडल लक्षण, अतालता और मां या चशशु में आईटर ोजेचनक हाइपरथायरायचडज्म। इसचलए, वैकक्टल्पक
उपिारों की जांि िल रही है। हबाल दवाओं ने प्रसवोत्तर मचहलाओं में दू ि उत्पादन के चलए सुरचक्षत और प्रभावी
उपिार की क्षमता चदखाई है। शतावरी को "आयुवेचदक जडी बूचटयों की रानी" के रूप में जाना जाता है। भारत में
गैलेक्टागॉग के रूप में इसके उपयोग का एक लंबा इचतहास रहा है और इस उपयोग के चलए आचिकाररक
आयुवेचदक फामााकोचपया में भी शाचमल है। यह फोचलक एचसड, चवटाचमन ए, सी, और के, और फाइटोएस्टर ोजेन से
भरा हुआ है; फाइटोएस्टर ोजेन का हामोनल प्रभाव दू ि उत्पादन में एस्टर ोजन की तरह है। प्रोलैक्टक्टन उत्पादन का
एक प्रमुख चनयामक एस्टर ोजेन है जो प्रोलैक्टक्टन उत्पादक कोचशकाओं के चवकास को बढाता है और प्रोलैक्टक्टन
उत्पादन को सीिे उत्तेचजत करता है, साथ ही डोपामाइन को दबाकर भी। इसमें चटर प्टोफैन भी होता है, एक
आवश्यक अमीनो एचसड जो प्रोलैक्टक्टन उत्पादन को उत्तेचजत कर सकता है, चजससे दू ि उत्पादन में वृक्टि होती
है।
शतावरी आमत र पर गोचलयों, कैप्सूल या पाउडर के रूप में उपलब्ध है। अब तक, यादृक्टिक चनयंचित परीक्षणों
सचहत अध्ययन 4-6 सप्ताह के चलए गैलेक्टागॉग के रूप में शतावरी के उपयोग का समथान करते हैं । हालांचक,
इस संकेत के चलए शतावरी की दीर्ाकाचलक प्रभावकाररता का अभी तक पता नहीं लगाया गया है। इस अध्ययन
का उद्दे श्य दू ि उत्पादन के चलए प्रसवोत्तर मचहला में गैलेक्टागॉग के रूप में गैलेक्ट ग्रैन्यूल (शतावरी फॉमूालेशन)
के संभाचवत लाभों की जांि करना है।

1
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

2. परीक्षण का उद्दे श्य:

नैदाचनक शोि अध्ययन चजसमें आपकी भागीदारी प्रस्ताचवत है, का उद्दे श्य गैलेक्ट ग्रैन्यूल (शतावरी फॉमूालेशन)
की प्रभावकाररता और सुरक्षा का मूल्ांकन करना है, पोस्ट-पाटा म मचहलाओं में गैलेक्टागॉग के रूप में: एक
संभाचवत, यादृक्टिक, डबल-ब्लाइं ड, प्लेसबो-चनयंचित अध्ययन।
संभाचवत का मतलब है चक आपको चिचकत्सा दी जाएगी, और हम अध्ययन चिचकत्सा शुरू करने के बाद चिचकत्सा
के प्रभावों का चनरीक्षण करें गे।
यादृक्टिक का मतलब है चक आपको यादृक्टिक तरीके से चिचकत्सा दी जाएगी, यानी, आपको पूरे अध्ययन अवचि
के द रान 'गैलेक्ट ग्रैन्यूल्स पाउडर' या 'समान प्रोटीन / प्लेसबो पाउडर' प्राप्त हो सकता है।
डबल-ब्लाइं ड का मतलब है चक आप और आपके उपक्टस्थत चिचकत्सक दोनों को आपके द्वारा प्राप्त उपिार के
बारे में पता नहीं होगा। इस प्रकार की अंिािुंि हमें अध्ययन के पररणामों में पूवााग्रह और िुचट को कम करने में
मदद करती है।
प्लेसबो का मतलब है चक पाउडर में शतावरी नहीं बक्टि कुछ अन्य चनक्टिय पदाथा होंगे। प्लेसीबो का उपयोग
करके, हमें पता िलता है चक सकारात्मक पररणाम शतावरी के कारण हैं या मनोवैज्ञाचनक कारकों के कारण हैं।
प्लेसबो-चनयंचित का मतलब है चक हम 'गैलेक्ट थेरेपी' या 'प्लेसबो थेरेपी' के पररणामों की तुलना करते हैं। इस
प्रकार, यहां प्लेसीबो एक चनयंिण या एक संदभा की तरह काया करता है चजसके साथ गैलेक्ट ग्रैन्यूल की तुलना की
जाती है।
उम्मीद है चक आपको इस दवा से फायदा होगा। इस अध्ययन में भाग लेने के चलए सहमत होने पर, आप अध्ययन
द्वारा आवश्यक अध्ययन गचतचवचियों और दवा अनुसूिी को करने के चलए जानबूझकर सहमत हैं।
इस अध्ययन से प्राप्त ज्ञान कई हजारों रोचगयों के चलए लाभकारी होगा, जो आपकी तरह, इस तरह की चिचकत्सा
क्टस्थचत से पीचडत हो सकते हैं।
3. पालन की जाने वाली प्रतिया:
इस अध्ययन में, कुल 110 रोचगयों को नामांचकत चकया जाएगा। प्रारं चभक यािा में, संभाचवत चवषयों को अध्ययन,
इचतहास और नैदाचनक परीक्षा की आवश्यकताओं के आिार पर नामांकन के चलए जांि की जाएगी। चकसी भी
अध्ययन से संबंचित प्रचियाओं को शुरू करने से पहले, आपको अध्ययन के बारे में चवस्तार से समझाया जाएगा
और इस अध्ययन में भाग लेने के चलए आपसे चलक्टखत सूचित सहमचत प्राप्त की जाएगी। यह दस्तावेज़ चलक्टखत
सूचित सहमचत प्रचिया का एक चहस्सा है।
संबंचित क्टस्थचतयों सचहत एक चवस्तृत चिचकत्सा इचतहास दजा चकया जाएगा। चकसी भी असामान्य पैरामीटर को
दे खने के चलए एक सामान्य और शारीररक परीक्षा की जाएगी। यचद आप पािता मानदं डों को पूरा करते हैं, तो
आपको अध्ययन में नामांचकत चकया जाएगा।
अध्ययन में नामांकन के बाद, आपको 2 िम्मि पाउडर गैलेक्ट ग्रैन्यूल (शतावरी (शतावरी रे समोसस युक्त) 15
ग्राम, चवदारी कांड (प्यूराररया ट्यूबरोज) 1 ग्राम, सोवा (एनेथुम सोवा) 1 ग्राम, गोखरू पंिांग (चटर बुलस टे रेक्टस्टरस)
2.5 ग्राम, यचष्ट्मिु (ग्लाइसीररजा ग्लबरा) 1 ग्राम, जीरा (सफेद) (क्यूचमनम चसचमनम) 1 ग्राम, अहचलव पाउडर
(लेचपचडयम सैचटवम) 1 ग्राम, इलाइिी स्वाद के साथ) या प्लेसबो / संदभा उत्पाद (गैलेक्ट ग्रैन्यूल की सामग्री के
चबना प्रोटीन चमश्रण युक्त।) 16 सप्ताह के चलए एक चगलास दू ि के साथ चदन में दो बार।
पूरे अध्ययन के द रान आपकी चनगरानी की जाएगी। प्रारं चभक यािा 1 (स्क्रीचनंग, बेसलाइन / यादृक्टिककरण)
(चदन 1) के बाद, आपको यािा 2 अनुवती (चदन 3- प्रसव के 72 र्ंटे बाद) पर मूल्ांकन के चलए क्टक्लचनक का द रा
करना होगा, 3 अनुवती (सप्ताह 4) पर जाएं , और अध्ययन के 4 अंत (सप्ताह 16) पर जाएं । प्रोलैक्टक्टन हामोन स्तर
के चलए रक्त का नमूना एकि चकया जाएगा और स्तन के दू ि का नमूना गुणवत्ता जांि के चलए चवचजट 1 (स्क्रीचनंग
चवचजट / नामांकन यािा / बेसलाइन चवचजट- चदन 1), चवचजट 3 (सप्ताह 4), और चवचजट 4 (सप्ताह 16) पर एकि
चकया जाएगा। । स्तन पररपूणाता के चलए व्यक्टक्तपरक मूल्ांकन और मां के आकलन द्वारा स्व-ररपोटा अपयााप्त दू ि
(एसआरआईएम) मूल्ांकन चकया जाएगा। अध्ययन अवचि की प्रत्येक यािा के द रान दुष्प्रभावों की चनगरानी की
जाएगी। अध्ययन 16 सप्ताह में पूरा हो जाएगा।
2
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

4. अध्ययन में भाग लेने के संभातवि जोच्छिम

सभी नई और पुरानी दवाओं के साथ, इस उपिार से जुडे कुछ अप्रत्याचशत जोक्टखम हो सकते हैं। डॉक्टर द्वारा
उचित स्क्रीचनंग परीक्षण और परीक्षाओं के साथ, चकसी भी संभाचवत नुकसान को कम करने के चलए अध्ययन को
चडजाइन करने के चलए दे खभाल की गई है।
अध्ययन के प्रभारी डॉक्टर / उपक्टस्थत चिचकत्सक आपको अध्ययन दवा से जुडे अन्य सभी जोक्टखमों के बारे में
बताएं गे।
शतावरी की प्रभावकाररता और सुरक्षा अिी तरह से स्थाचपत की गई है और इसका उपयोग आयुवेद के प्रािीन
काल से चकया जाता रहा है। इसचलए, यह संभावना नहीं है चक आप अध्ययन में ली जाने वाली खुराक में अध्ययन
उपिार के साथ चकसी भी दु ष्प्रभाव का अनुभव कर सकते हैं।
5. अध्ययन के लाभ:
अध्ययन चिचकत्सा आपको स्तन के दू ि की मािा और गुणवत्ता में सुिार के चलए भी लाभाक्टित कर सकती है।
इसचलए यह संभव है चक यह आपके लक्षणों में भी सुिार कर सकता है। प्रायोजक द्वारा आपको अध्ययन दवा
मुफ्त प्रदान की जाएगी। हालांचक, अध्ययन क्टक्लचनक/अस्पताल की यािा करने और क्टक्लचनक में जाने के कारण
मजदू री/आय की हाचन के चलए आपको कोई मुआवजा नहीं चदया जाएगा।
इस अध्ययन से प्राप्त ज्ञान उनके प्रसवोत्तर अवचि में कई हजारों मचहलाओं के चलए लाभकारी होगा।
6. वैकच्छिक उपचार:
दू ि उत्पादन को चवश्राम तकनीकों और मनोवैज्ञाचनक समथान द्वारा बढाया जा सकता है, कई माताएं अपने स्तनपान
को बढाने के चलए दवाओं या अन्य उत्पादों का उपयोग करती हैं।
7. ररकॉडष की गोपनीयिा:
इस परीक्षण से संबंचित आपके मेचडकल ररकॉडा गोपनीयता में बनाए रखे जाएं गे। प्रायोजक (एमक्योर
फामाास्यूचटकल्स चलचमटे ड) से चिचकत्सा चनगरानी और गुणवत्ता आिासन प्रचतचनचि, भारत। यचद इन अचभलेखों से
आपका नाम पहिाना नहीं जा सकता है तो आप अपने मेचडकल ररकॉडा की जांि कर सकते हैं।
इस परीक्षण से आपके ररकॉडा प्रायोजक द्वारा सरकारी अचिकाररयों को प्रस्तुत चकए जा सकते हैं जो राज्य और
दे श में दवाओं को चनयंचित करते हैं, लेचकन ऐसे ररकॉडा से आपका नाम नहीं पहिाना जाएगा। इस परीक्षण में
चकसी भी चवचशष्ट् रोगी की पहिान चकसी भी सावाजचनक ररपोटा या प्रकाशनों में प्रकट नहीं की जाएगी।
प्राचिकरण को आपके नाम के साथ प्रासंचगक मेचडकल ररकॉडा और अन्य डे टा की समीक्षा करने के चलए उचित
न्याचयक आदे श पर अचिकार है। वे कानून द्वारा आवश्यक हैं; हालांचक, जानकारी को गोपनीय तरीके से संभाला
जाएगा।
8. अध्ययन में आपकी भागीदारी और आपके अतिकार
इस अध्ययन में आपकी भागीदारी स्वैक्टिक है और आप इसके चलए कारण बताए चबना चकसी भी समय अध्ययन
से हट सकते हैं। चकसी भी मामले में, आपको अपनी क्टस्थचत के चलए उचित उपिार चदया जाएगा। भाग लेने से
इनकार करने में शोि अध्ययनों में बाद में भागीदारी के संदभा में कोई जुमााना शाचमल नहीं होगा। आप उपक्टस्थत
चिचकत्सक के साथ पूरी तरह से सहयोग करने के चलए सहमत होंगे।
यचद चकसी भी समय आप बदतर महसूस करते हैं या चकसी अन्य बीमारी से पीचडत हैं, तो कृपया अपने उपक्टस्थत
चिचकत्सक को सूचित करें । यचद उपिार आपके चलए अनुपयुक्त प्रतीत होता है, तो इसे रोक चदया जाएगा। यह
संभव है चक आपकी सहमचत के चबना अध्ययन को रोका जा सकता है। आपका डॉक्टर आपको बताएगा चक क्या
अध्ययन के द रान कोई नई जानकारी ज्ञात हो जाती है, जो अध्ययन में जारी रखने की आपकी इिा को प्रभाचवत
कर सकती है।
यचद आप अध्ययन के द रान चकसी भी उपिार से संबंचित िोट से पीचडत हैं, तो प्रायोजक उस िोट के इलाज के
चलए चिचकत्सा व्यय का भुगतान करे गा। प्रायोजक से कोई अन्य मुआवजा उपलब्ध नहीं है।

3
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

9. यतद आपके पास दवा की जानकारी और सुरक्षा से संबंतिि कोई प्रश्न िैं, िो आप अध्ययन के मेतडकल
मॉतनटर से संपकष कर सकिे िैं।
नाम : डॉ प्राजक्ता वांगीकर, पीएिडी
पिा : प्रबंिक, चिचकत्सा सेवा,
एमक्योर फामाास्युचटकल्स चलचमटेड,
ओबेरॉय गाडा न एस्टे ट्स, यादव नगर,
िांदीवली, पवई, मुंबई 400072, महाराष्ट्र।
दू रध्वनी: +91 97698 51047
ई मेल : [email protected]
10. यतद कोई समस्या उत्पन्न िोिी िै, िो आप अन्वेर्क से संपकष कर सकिे िैं
यचद कोई गंभीर समस्या चवकचसत होती है, तो आपको शीघ्र और उचित चिचकत्सा ध्यान चदया जाएगा। यह सहमचत
है चक उपयुाक्त अस्पताल की सुचविाएं आपको उपलब्ध कराई जाएं गी।
उपयुाक्त अस्पताल के माध्यम से प्रदान चकए जाने पर उचित चिचकत्सा उपिार मुफ्त होगा।
कहीं और चिचकत्सा उपिार, काम की हाचन, या अन्य खिों के चलए चवत्तीय मुआवजा उपलब्ध नहीं है।
11. यतद आपके पास नैतिक मुद्दों और आपके अतिकारों से संबंतिि कोई प्रश्न िैं, िो आप आईईसी
संकाय से तनम्नतलच्छिि से संपकष कर सकिे िैं।
नाम : डॉ. ज्ञानेश बेलेकर,
अध्यक्ष आईईसी,
पिा : जैव चिचकत्सा और स्वास्थ्य दे खभाल अनुसंिान के चलए आईईसी
डी वाई पाचटल मेचडकल कॉलेज एं ड हॉक्टस्पटल, नवी मुंबई
दू रध्वनी: 80822 88852
ई मेल: [email protected]
12. तवत्तीय तवचार:
आपकी सुरक्षा सुचनचित करने की हमारी प्रचतबिता के चहस्से के रूप में, एमक्योर चकसी भी शोि से संबंचित िोटों
या अप्रत्याचशत र्टनाओं के चलए बीमा कवरे ज प्रदान करे गा जो इस परीक्षण में आपकी भागीदारी के द रान हो
सकते हैं।
13. अतिररक्त जानकारी प्राप्त करना:
आपको इस समय आपके साथ होने वाले चकसी भी प्रश्न को पूछने या परीक्षण में आपकी भागीदारी के द रान चकसी
भी समय प्रश्न पूछने के चलए प्रोत्साचहत चकया जाता है। आपको अपनी जानकारी के चलए इस दस्तावेज़ की एक
प्रचत दी जाएगी। यचद आप बाद में अचिक जानकारी िाहते हैं, तो आप साइट पर अिेषक या अध्ययन टीम के
चकसी भी सदस्य को कॉल कर सकते हैं।
14. दस्िख़ि दे च्छिए।
मैंने उपरोक्त जानकारी पढी है और मुझे कोई भी प्रश्न पूछने का अवसर चमला है और मेरे सभी प्रश्नों का उत्तर चदया
गया है।
मुझे ऐसा करने का कारण बताए चबना मुकदमे के द रान चकसी भी समय मुकदमे से बाहर चनकलने के अपने
अचिकार के बारे में भी पता है।
मुझे सूिना पि और सहमचत फॉमा की एक प्रचत दी गई है।

4
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

रोगी का नाम: _______________________________________________________

िस्ताक्षर/अंगूठे का तनशान: _______________________ तदनांक: ___________

तनष्पक्ष गवाि का नाम: _________________________________________________

िस्ताक्षर/अंगूठे का तनशान: _______________________ तदनांक: ____________

मैंने, अिोहस्ताक्षरी, ने स्थानीय भाषा में इस परीक्षण के प्रासंचगक चववरण को ऊपर नाचमत रोगी और/या रोगी के
चलए सहमचत के चलए अचिकृत चकया है। मैं इस भूचमका को चनभाने के चलए योग्य हं।
(चनरक्षर पीटी के मामले में)

अन्वेर्क का नाम: ____________________________________________________

दस्िख़ि दे च्छिए।: ____________________________________ तदनांक: ____________

5
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
अध्ययन कोड: Galactagogure-1089-2024-01 सूचित सहमचत दस्तावेज़ (ICD)
आईसीडी-अंग्रेजी, संस्करण -1, डीटी। 15 फरवरी 2024 रोगी स्क्रीचनंग संख्या: |__|__| − |__|__|__|

सूतचि सिमति प्रपत्र (ICF)

प्रोटोकॉल शीर्षक : पोस्ट-पाटष म मतिलाओं में गैलेक्टागॉग के रूप में गैलेक्ट ग्रैन्यूल (शिावरी
फॉमूषलेशन) की प्रभावकाररिा और सुरक्षा का मूल्ांकन: एक संभातवि,
यादृच्छिक, डबल-ब्लाइं ड, प्लेसबो-तनयंतत्रि अध्ययन
अध्ययन कोड : गैलेक्टागोगुर-1089-2024-01; संस्करण 1; डीटी। 12 फरवरी 2024
रोगी का नाम : ____________________________________________________

उम्र:______ साल नहीं तो जन्मचतचथ ____ / ____ / ____

रोगी के आद्याक्षर: ______

रोगी के
िमांक
आद्याक्षर
मैं पुचष्ट् करता हं चक मैंने उपरोक्त अध्ययन के चलए सूिना पि को पढा और समझा है और
1.
प्रश्न पूछने का अवसर चमला है।
मैं समझता हं चक अध्ययन में मेरी भागीदारी स्वैक्टिक है और मैं चकसी भी समय, चबना कोई
2. कारण बताए, चबना चकसी चिचकत्सा या कानूनी अचिकार को प्रभाचवत चकए वापस लेने के चलए
स्वतंि हं।
मैं समझता हं चक नैदाचनक परीक्षण के प्रायोजक, प्रायोजक की ओर से काम करने वाले अन्य,
चनयामक अचिकाररयों को वतामान अध्ययन और भचवष्य के चकसी भी शोि के संबंि में मेरे
3. स्वास्थ्य ररकॉडा को दे खने के चलए मेरी अनुमचत की आवश्यकता नहीं होगी, भले ही वह
परीक्षण से वापस ले ले। मैं इस पहुंि से सहमत हं। हालांचक, मैं समझता हं चक तीसरे पक्ष को
जारी या प्रकाचशत चकसी भी जानकारी में उसकी पहिान प्रकट नहीं की जाएगी।
मैं इस अध्ययन से उत्पन्न होने वाले चकसी भी डे टा या पररणामों के उपयोग को प्रचतबंचित नहीं
4.
करने के चलए सहमत हं।
5. मैं इसके द्वारा उपरोक्त अध्ययन में भाग लेने के चलए सहमत हं
मुझे रोगी सूिना पि में चवस्तार से उपरोक्त संदचभात अध्ययन की प्रचियाओं और यािाओं की
6.
संख्या के बारे में सूचित चकया गया है
7. मुझे संभाचवत जोक्टखमों और लाभों (रोगी सूिना पिक में) के बारे में समझाया गया है।

रोगी के िस्ताक्षर/अंगूठे का तनशान: _____________________________________ तदनांक: __________________

अन्वेर्क का िस्ताक्षर: __________________________________________________ तदनांक: __________________

तनष्पक्ष गवाि के िस्ताक्षर: _______________________________________________तदनांक: ______________

(तनरक्षर पीटी के मामले में)

6
रोगी/चनष्पक्ष गवाह के हस्ताक्षर/अंगूठे का चनशान
(दो प्रचतयों में चनष्पाचदत चकया जाना है और एक प्रचत चवषय/रोगी को स प
ं ी जानी है)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

सहभागी माहहती पत्रक (पीआयएस)

प्रोटोकॉल शीर्षक : पोस्ट-पाटष म महहलाांमध्ये गॅलॅक्टॅगॉग म्हणून गॅलॅक्ट ग्रॅन्युल्सची

कायषक्षमता आहण सुरहक्षततेचे मूल्ाांकन (शतावरी फॉर्म्ुषलेशन): एक
सांभाव्य, यादृच्छिक, दु हेरी-अांध, प्लेसबो-हनयांहत्रत अभ्यास
स्टडी कोड : गॅलॅक्टागोर-1089-2024-01; आवृत्ती 1; डी.टी. 12 फेब्रुवारी 2024
रुग्णािे िाव : ______________________________________

डॉक्टरिे िाव : डॉ. अचििी दे शमुख

रुग्णालयािे िाव : सहयोगी प्राध्यापक,
प्रसूती व स्त्रीरोग चवभाग,
डी. वाय. पाटील वैद्यकीय महाचवद्यालय व रुग्णालय,
िेरुळ, िवी मुंबई 400706, महाराष्ट्र.
प्रायोजकािे िाव : एमक्युर फामादस्युचटकल्स चलचमटे ड, भारत.
प्रायोजकािा पत्ता : एम्क्क्युअर फामादस्युचटकल्स चल.,
ओबेरॉय गाडद ि इस्टे ट, यादव िगर,
िांचदवली, पवई, मुंबई 400072, महाराष्ट्र.
1. पररचय:
प्रसुतीपूवद कालावधी बाळाच्या प्रसूतीिंतर लगेिि सुरू होतो आचण सहसा सहा ते आठ आठवडे चटकतो
आचण जेव्हा आईिे शरीर जवळजवळ गभदधारणेपूवीच्या प्लथितीत परत येते तेव्हा संपते. लॅक्टोजेिेचसस
(दू ध उत्पादि) ही एक जचटल न्यूरोचफचजओलॉचजकल प्रचक्रया आहे ज्यामध्ये अिेक संप्रेरकांिी चक्रया
असते, मुख्यत: प्रोलॅप्लक्टि. चिप्पल उत्तेजिाला प्रचतसाद म्हणूि पूवदचपट्यूटरी ग्रंिीद्वारे प्रोलॅप्लक्टि स्राचवत
केले जाते. आयुष्याच्या पचहल्या सहा मचहन्यांत, आईिे दू ध बाळांसाठी पोषणािा इष्ट्तम स्त्रोत आहे.
स्तिपाि अपयशािे सवादत सामान्य कारण म्हणजे आईच्या दु धािे अपुरे उत्पादि, ज्यास स्तिपाि
अपुरेपणा दे खील म्हणतात.
मेटोक्लोप्रामाइड, ऑप्लिटोचसि, डोम्पेररडोि, क्लोरप्रोमाचिि आचण सप्लिराइड सारख्या गॅलॅक्टॅगॉग
औषधे चिरोगी मातांमध्ये सध्याच्या उपिारात्मक धोरणां पैकी एक आहेत. तिाचप, ही औषधे आई चकंवा
अभदकामध्ये एक्स्ट्र ाचपराचमडल लक्षणे, एररिचमया आचण आयटर ोजेचिक हायपरिायरॉईडीिम सारख्या
प्रचतकूल प्रभावांशी संबंचधत आहेत. त्यामुळे पयादयी उपिारांिी तपासणी सुरू आहे. हबदल औषधांिी
प्रसूतीिंतरच्या प्लस्त्रयांमध्ये दू ध उत्पादिासाठी सुरचक्षत आचण प्रभावी उपिारांिी क्षमता दशदचवली आहे.
शतावरी ला "आयुवेचदक औषधी विस्पतींिी राणी" म्हणूि ओळखले जाते. भारतात गॅलॅक्टगॉग म्हणूि
यािा वापर करण्यािा दीर्द इचतहास आहे आचण या वापरासाठी अचधकृत आयुवेचदक फामादकोचपयामध्ये
दे खील यािा समावेश आहे. हे फॉचलक अॅचसड, प्लव्हटॅ चमि ए, सी आचण के आचण फायटोएस्टर ोजेििे भरलेले
आहे; फायटोएस्टर ोजेििा हामोिल प्रभाव दू ध उत्पादिात इस्टर ोजेिसारखा असतो. प्रोलॅप्लक्टि उत्पादिािा
एक मुख्य चियामक म्हणजे एस्टर ोजेि जे प्रोलॅप्लक्टि-उत्पादक पेशींिी वाढ वाढवते आचण िेट प्रोलॅप्लक्टि
उत्पादिास उत्तेजि दे ते, तसेि डोपामाइि दडपूि टाकते. यात चटर प्टोफेि, एक आवश्यक अचमिो आम्ल
दे खील आहे जे प्रोलॅप्लक्टि उत्पादिास उत्तेजि दे ऊ शकते, ज्यामुळे दु धािे उत्पादि वाढते.
शतावरी सामान्यत: गोळ्या, कॅप्सूल चकंवा पावडरच्या स्वरूपात उपलब्ध असते. आतापयंत, यादृप्लिक
चियंचित िािण्यांसह अभ्यास 4-6 आठवड्ांसाठी गॅलॅक्टगॉग म्हणूि शतावरीच्या वापरास समिदि दे तात.

1
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

तिाचप, या संकेतासाठी शतावरीिी दीर्दकालीि कायदक्षमता अद्याप शोधली गेली िाही. या अभ्यासािे
उद्दीष्ट् दू ध उत्पादिासाठी पोस्ट-पाटद म मचहलेमध्ये गॅलॅक्टगॉग म्हणूि गॅलॅक्ट ग्रॅन्युल्स (शतावरी
फॉर्म्ुदलेशि) च्या संभाव्य फायद्यांिी तपासणी करणे आहे.
2. चाचणीचा उद्दे श:
प्लक्लचिकल संशोधि अभ्यास ज्यामध्ये आपला सहभाग प्रस्ताचवत आहे त्यािे उद्दीष्ट् पोस्ट-पाटद म
मचहलांमध्ये गॅलॅक्टगॉग म्हणूि गॅलॅक्ट ग्रॅन्युल्स (शतावरी फॉर्म्ुदलेशि) िी कायदक्षमता आचण सुरचक्षततेिे
मूल्यांकि करणे आहे: एक संभाव्य, यादृप्लिक, दु हेरी-अंध, िेसबो-चियंचित अभ्यास.
संभाव्य म्हणजे आपल्याला िेरपी चदली जाईल आचण अभ्यास िेरपी सुरू केल्यािंतर आम्ही िेरपीच्या
पररणामांिे चिरीक्षण करू.
यादृप्लिक म्हणजे आपल्याला यादृप्लिक पद्धतीिे िेरपी चदली जाईल, म्हणजेि संपूणद अभ्यास कालावधीत
आपल्याला 'गॅलॅक्ट ग्रॅन्युल्स पावडर' चकंवा 'समाि प्रचििे / िेसबो पावडर' चमळू शकते.
डबल-ब्लाइं ड िा अिद असा आहे की आपल्याला आचण आपल्या उपप्लथित डॉक्टरांिा आपल्याला
चमळालेल्या उपिारांिी माचहती िसते. या प्रकारच्या अंधत्वामुळे आम्हाला अभ्यासाच्या चिकालांमधील
पूवदग्रह आचण िुटी कमी होण्यास मदत होते.
िेसबो म्हणजे पावडरमध्ये शतावरी िसूि इतर काही चिप्लिय पदािद असतील. िेसबो वापरूि,
आपल्याला कळते की सकारात्मक पररणाम शतावरीमुळे आहेत की मािचसक र्टकांमुळे.
िेसबो-चियंचित म्हणजे आपण 'गॅलॅक्ट िेरपी' चकंवा 'िेसबो िेरपी'च्या पररणामांिी तुलिा करतो. अशा
प्रकारे , येिे िेसबो चियंिण चकंवा संदभादसारखे कायद करते ज्याशी गॅलॅक्ट ग्रॅन्युल्सिी तुलिा केली जाते.
या औषधािा तुम्हाला फायदा होईल, अशी अपेक्षा आहे. या अभ्यासात भाग र्ेण्यास सहमत िाल्यावर,
आपण जाणूिबुजूि अभ्यासाद्वारे आवश्यकतेिुसार अभ्यास चक्रयाकलाप आचण औषधोपिार वेळापिक
करण्यास सहमत आहात.
या अभ्यासातूि चमळालेल्या ज्ञािािा तुमच्याप्रमाणेि अशा प्रकारच्या वैद्यकीय प्लथितीिे िस्त असलेल्या
हजारो रुग्णांिा फायदा होईल.
3. अनुसरण करावयाची कायषपद्धती:
या अभ्यासामध्ये, एकूण 110 रूग्णांिी िोंदणी केली जाईल. सुरुवातीच्या भेटीत, संभाव्य चवषयांिा
अभ्यास, इचतहास आचण प्लक्लचिकल परीक्षेच्या आवश्यकतांच्या आधारे िाविोंदणीसाठी तपासणी केली
जाईल. अभ्यासाशी संबंचधत कोणतीही प्रचक्रया सुरू करण्यापूवी, आपल्याला अभ्यासाबद्दल तपशीलवार
समजावूि सांचगतले जाईल आचण या अभ्यासात भाग र्ेण्यासाठी आपल्याकडू ि लेखी संमती र्ेतली जाईल.
हा दस्तऐवज लेखी सूचित संमती प्रचक्रयेिा एक भाग आहे.
संबंचधत अटींसह तपशीलवार वैद्यकीय इचतहास िोंदचवला जाईल. कोणतेही असामान्य मापदं ड
पाहण्यासाठी सामान्य आचण शारीररक तपासणी केली जाईल. जर आपण पाितेिे चिकष पूणद केले तर
आपल्याला अभ्यासात प्रवेश चदला जाईल.
अभ्यासात िाविोंदणी केल्यािंतर, आपल्याला गॅलॅक्ट ग्रॅन्युल्सिी 2 िमिे पावडर (शतावरी (शतावरी
(शतावरी रे समोसस) 15 ग्रॅम, चवदारी कंद (प्युरेररया ट्यूबरोज) 1 ग्रॅम, सोवा (अिेिुम सोवा) 1 ग्रॅम, गोखरू
पंिांग (टर ायब्युलस टे रेस्टरीस) 2.5 ग्रॅम, यष्ट्ीमधू (ग्लायचसररिा ग्लॅब्रा) 1 ग्रॅम, जीरा (सफेद) (चजरे अम
सायचमिम) 1 ग्रॅम, अचहलीव पावडर (लेचपचडयम सॅचटव्हम) 1 ग्रॅम खाण्यास सांचगतले जाईल. इलायिी
िवसह) चकंवा िेसबो / संदभद उत्पादि (गॅलॅक्ट ग्रॅन्युल्सच्या सामग्रीचशवाय प्रचििे चमश्रण असलेले) 16
आठवड्ांसाठी दररोज दोिदा एक ग्लास दु धासह.

2
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

संपूणद अभ्यासादरर्म्ाि आपले चिरीक्षण केले जाईल. प्रारं चभक प्लव्हचजट 1 (स्क्रीचिंग, बेसलाइि /
रें डमाइजेशि) (चदवस 1) िंतर, आपल्याला प्लव्हचजट 2 फॉलो-अप (प्रसूतीिंतर चदवस 3- 72 तास), भेट 3
पाठपुरावा (आठवडा 4) आचण अभ्यासाच्या 4 शेवटी (आठवडा 16) मूल्यांकिासाठी प्लक्लचिकला भेट
द्यावी लागेल. प्रोलॅप्लक्टि संप्रेरक पातळीसाठी रक्तािे िमुिे गोळा केले जातील आचण प्लव्हचजट 1 (स्क्रीचिंग
प्लव्हचजट / एिरोलमेंट प्लव्हचजट / बेसलाइि प्लव्हचजट - चदवस 1), प्लव्हचजट 3 (आठवडा 4) आचण प्लव्हचजट 4
(आठवडा 16) वर गुणवत्ता तपासणीसाठी आईच्या दु धािा िमुिा गोळा केला जाईल. आईच्या
मूल्यांकिाद्वारे स्तिाच्या पररपूणदतेसाठी व्यप्लक्तचिष्ठ मूल्यांकि आचण स्वयं-अहवाचलत अपुरे दू ध
(एसआरआयएम) मूल्यांकि केले जाईल. अभ्यास कालावधीच्या प्रत्येक भेटीदरर्म्ाि दु ष्पररणामांिे
परीक्षण केले जाईल. हा अभ्यास १६ आठवड्ांत पूणद होईल.
4. अभ्यासात भाग घेण्याचे सांभाव्य धोके
सवद िवीि आचण जुन्या औषधांप्रमाणेि या उपिारांशी संबंचधत काही अिपेचक्षत जोखीम असू शकतात.
डॉक्टरांकडू ि योग्य स्क्रीचिंग िािण्या आचण तपासणीसह कोणतेही संभाव्य िुकसाि कमी करण्यासाठी
अभ्यासािी रििा करण्यािी काळजी र्ेण्यात आली आहे.
अभ्यासािे प्रभारी डॉक्टर / उपप्लथित डॉक्टर आपल्याला अभ्यास औषधाशी संबंचधत इतर सवद जोखीम
समजावूि सांगतील.
शतावरीिी कायदक्षमता आचण सुरचक्षतता िांगल्या प्रकारे थिाचपत िाली आहे आचण आयुवेदाच्या प्रािीि
काळापासूि यािा वापर केला जात आहे. म्हणूिि, आपण अभ्यासात र्ेत असलेल्या डोसमध्ये आपल्याला
अभ्यास उपिारांसह कोणतेही दु ष्पररणाम जाणवण्यािी शक्यता िाही.
5. अभ्यासाचे फायदे :
आईच्या दु धािे प्रमाण आचण गुणवत्ता सुधारण्यासाठी अभ्यास िेरपी आपल्याला फायदे शीर ठरू शकते.
म्हणूिि हे शक्य आहे की यामुळे आपली लक्षणे दे खील सुधारू शकतात. प्रायोजकाकडू ि आपल्याला
अभ्यासािे औषध चविामूल्य प्रदाि केले जाईल. तिाचप, अभ्यास प्लक्लचिक / रुग्णालयात प्रवास केल्याबद्दल
आचण प्लक्लचिकमध्ये गेल्यामुळे वेति / उत्पन्न गमावल्याबद्दल आपल्याला कोणतीही भरपाई चदली जाणार
िाही.
या अभ्यासातूि चमळालेल्या ज्ञािािा हजारो मचहलांिा प्रसूतीिंतरच्या काळात फायदा होणार आहे.
6. वैकच्छिक उपचार:
चवश्रांती तंि आचण मािचसक समिदिाद्वारे दु धािे उत्पादि वाढचवले जाऊ शकते, अिेक माता स्तिपाि
वाढचवण्यासाठी औषधे चकंवा इतर उत्पादिे वापरतात.
7. रे कॉर्ष ची गोपनीयता:
या िािणीशी संबंचधत आपल्या वैद्यकीय िोंदी गोपिीयतेत ठे वल्या जातील. प्रायोजक (एमक्युर
फामादस्युचटकल्स चलचमटे ड) कडू ि वैद्यकीय मॉचिटर आचण गुणवत्ता आिासि प्रचतचिधी., भारत.) या
िोंदींमधूि आपले िाव ओळखता येत िसल्यास आपल्या वैद्यकीय िोंदी तपासू शकता.
या िािणीतील आपल्या िोंदी प्रायोजकाकडू ि राज्य आचण दे शातील औषधांवर चियंिण ठे वणार् या
सरकारी प्राचधकरणांकडे सादर केल्या जाऊ शकतात, परं तु अशा िोंदींमधूि आपले िाव ओळखले
जाणार िाही. या िािणीतील कोणत्याही चवचशष्ट् रुग्णािी ओळख कोणत्याही सावदजचिक अहवालात चकंवा
प्रकाशिात उर्ड केली जाणार िाही.
योग्य न्यायालयीि आदे शावर प्राचधकरणाला आपले िाव ओळखलेल्या संबंचधत वैद्यकीय िोंदी आचण इतर
डे टािे पुिरावलोकि करण्यािा अचधकार आहे. ते कायद्यािे आवश्यक आहेत; माि, ही माचहती गोपिीय

3
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

पद्धतीिे हाताळली जाणार आहे.

8. अभ्यासातील आपला सहभाग आहण आपले हक्क
या अभ्यासात आपला सहभाग ऐप्लिक आहे आचण आपण त्यािे कारण ि दे ता कोणत्याही वेळी
अभ्यासातूि मार्ार र्ेऊ शकता. कोणत्याही पररप्लथितीत, आपल्याला आपल्या प्लथितीसाठी योग्य उपिार
चदले जातील. सहभागी होण्यास िकार चदल्यास संशोधि अभ्यासातील पुढील सहभागाच्या बाबतीत
कोणताही दं ड आकारला जाणार िाही. आपण उपप्लथित डॉक्टरांिा पूणद सहकायद करण्यास सहमत व्हाल.
जर कोणत्याही वेळी आपल्याला वाईट वाटत असेल चकंवा इतर कोणत्याही आजारािे ग्रस्त असाल तर
कृपया आपल्या उपप्लथित डॉक्टरांिा कळवा. जर उपिार आपल्यासाठी अयोग्य असल्यािे चदसूि आले
तर ते िांबचवले जाईल. हे शक्य आहे की आपल्या संमतीचशवाय अभ्यास िांबचवला जाऊ शकतो.
अभ्यासादरर्म्ाि कोणतीही िवीि माचहती ज्ञात िाल्यास आपले डॉक्टर आपल्याला सांगतील, ज्यामुळे
अभ्यासात िालू ठे वण्याच्या आपल्या इिे वर पररणाम होऊ शकतो.
अभ्यासादरर्म्ाि आपल्याला उपिारांशी संबंचधत कोणतीही दु खापत िाल्यास, प्रायोजक त्या दु खापतीच्या
उपिारांिा वैद्यकीय खिद दे ईल. प्रायोजकाकडू ि इतर कोणतीही भरपाई चमळत िाही.
9. आपल्ाकर्े और्धाची माहहती आहण सुरहक्षततेशी सांबांहधत काही प्रश्न असल्ास, आपण
अभ्यासाच्या वैद्यकीय मॉहनटरशी सांपकष साधू शकता.
नाव: डॉ. प्राजक्ता वांगीकर, पीएि.डी.
पत्ता: मॅिेजर, मेचडकल सप्लव्हदसेस,
एम्क्क्युअर फामादस्युचटकल्स चल.,
ओबेरॉय गाडद ि इस्टे ट, यादव िगर,
िांचदवली, पवई, मुंबई 400072, महाराष्ट्र.
टे लीफोन : +91 97698 51047
ई-मेल : [email protected]
10. कोणतीही समस्या उद्भवल्ास आपण तपासकर्त्ाषशी सांपकष साधू शकता
जर कोणतीही गंभीर समस्या उद्भवली तर आपल्याला त्वररत आचण योग्य वैद्यकीय मदत चमळे ल. उपरोक्त
रुग्णालयातील सुचवधा आपल्याला उपलब्ध करूि चदल्या जातील हे मान्य आहे.
उपरोक्त रुग्णालयामाफदत योग्य वैद्यकीय उपिार चदल्यास योग्य वैद्यकीय उपिार मोफत चमळतील.
इतरि वैद्यकीय उपिार, कामािे िुकसाि चकंवा इतर खिादसाठी आचिदक िुकसाि भरपाई चमळत िाही.
11. आपल्ाकर्े नैहतक समस्या आहण आपल्ा हक्काांशी सांबांहधत काही प्रश्न असल्ास, आपण
आयईसी फॅकल्टीकर्ून खालील शी सांपकष साधू शकता.
नाव: र्ॉ. ज्ञानेश बेलेकर,
अध्यक्ष आयईसी,
पत्ता: बायोमेचडकल अँड हेल्थ केअर ररसिदसाठी आयईसी
डी. वाय. पाटील वैद्यकीय महाचवद्यालय व रुग्णालय, िवी मुंबई
टे लीफोन: 80822 88852
ई मेल: [email protected]
12. आहथषक हवचार:
4
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

आपले संरक्षण सुचिचित करण्याच्या आमच्या वििबद्धतेिा एक भाग म्हणूि, एमक्योर या िािणीत
आपल्या सहभागादरर्म्ाि उद्भवू शकणायाद कोणत्याही संशोधि-संबंचधत जखमा चकंवा अिपेचक्षत
र्टिांसाठी चवमा संरक्षण प्रदाि करे ल.
13. अहधक माहहती हमळवणे:
या वेळी आपल्याला उद्भवणारे कोणतेही प्रश्न चविारण्यास चकंवा िािणीमध्ये आपल्या सहभागादरर्म्ाि
कोणत्याही वेळी प्रश्न चविारण्यास प्रोत्साचहत केले जाते. स्वत: च्या माचहतीसाठी तुम्हाला या कागदपिािी
प्रत चदली जाईल. आपल्याला िंतर अचधक माचहती हवी असल्यास, आपण अन्वेषक चकंवा साइटवरील
अभ्यास कायदसंर्ाच्या कोणत्याही सदस्यास कॉल करू शकता.
14. स्वाक्षरी
मी वरील माचहती वािली आहे आचण कोणतेही प्रश्न चविारण्यािी संधी चमळाली आहे आचण माझ्या सवद
प्रश्नांिी उत्तरे चमळाली आहेत.
खटल्यादरर्म्ाि कोणत्याही वेळी कारण ि दे ता खटल्यातूि बाहेर पडण्यािा मािा अचधकारही मला
ठाऊक आहे.
मला माचहती पिक आचण संमती पिािी प्रत दे ण्यात आली आहे.

रुग्णाचे नाव: _______________________________________________________

स्वाक्षरी / अांगठ्याचा ठसा: _______________________ तारीख: ___________

हनष्पक्ष साक्षीदाराचे नाव: _________________________________________________

स्वाक्षरी / अांगठ्याचा ठसा: _______________________ तारीख: ____________

मी वर उल्लेख केलेल्या आचण / चकंवा रूग्णासाठी संमती दे ण्यास अचधकृत असलेल्या रुग्णाला या
िािणीिा संबंचधत तपशील थिाचिक भाषेत पूणदपणे समजावूि सांचगतला आहे. ही भूचमका पार
पाडण्यासाठी मी पाि आहे.
(चिरक्षर पी.टी.एस. च्या बाबतीत)

अन्वेर्काचे नाव: ____________________________________________________

स्वाक्षरी: ____________________________________ तारीख: ____________

5
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
स्टडी कोड: गॅलॅक्टागोर-1089-2024-01 सूचित संमती दस्तऐवज (आयसीडी)
आयसीडी-इं ग्रजी, आवृत्ती-१, डीटी. 15 फेब्रुवारी 2024 रुग्ण तपासणी क्रमांक: |_____| − |__|__|__|

सूहचत सांमती फॉमष (आयसीएफ)

प्रोटोकॉल शीर्षक : पोस्ट-पाटष म महहलाांमध्ये गॅलॅक्टॅगॉग म्हणून गॅलॅक्ट ग्रॅन्युल्सची

कायषक्षमता आहण सुरहक्षततेचे मूल्ाांकन (शतावरी फॉर्म्ुषलेशन): एक
सांभाव्य, यादृच्छिक, दु हेरी-अांध, प्लेसबो-हनयांहत्रत अभ्यास
स्टडी कोड : गॅलॅक्टागोर-1089-2024-01; आवृत्ती 1; डी.टी. 12 फेब्रुवारी 2024
रुग्णािे िाव : ____________________________________________________

वय:______ वषादिुवषे चकंवा डीओबी ____ / ____ / ____

रूग्ण आद्याक्षरे : ______

रूग्ण
आद्याक्षरे
मी पुष्ट्ी करतो की मी वरील अभ्यासासाठी माचहतीपिक वािले आहे आचण समजूि
1.
र्ेतले आहे आचण मला प्रश्न चविारण्यािी संधी चमळाली आहे.
मी समजतो की अभ्यासात मािा सहभाग ऐप्लिक आहे आचण मी कोणत्याही वेळी,
2. कोणतेही कारण ि दे ता, कोणत्याही वैद्यकीय चकंवा कायदे शीर अचधकारांवर पररणाम
ि करता मार्ार र्ेण्यास मोकळा आहे.
मी समजतो की प्लक्लचिकल िािणीिे प्रायोजक, प्रायोजकाच्या वतीिे काम करणारे
इतर, चियामक प्राचधकरणांिा सध्याच्या अभ्यासाच्या संदभादत आचण त्यासंदभादत
भचवष्यात केले जाऊ शकणायाद कोणत्याही संशोधिाच्या संदभादत माझ्या आरोग्याच्या
3. िोंदी पाहण्यासाठी माझ्या परवािगीिी आवश्यकता िाही, जरी त्यािे / चतिे िािणीतूि
मार्ार र्ेतली तरीही. या प्रवेशाशी मी सहमत आहे. तिाचप, मी समजतो की तृतीय
पक्षांिा जारी केलेल्या चकंवा प्रकाचशत केलेल्या कोणत्याही माचहतीमध्ये त्यािी / चतिी
ओळख उर्ड केली जाणार िाही.
मी या अभ्यासातूि उद्भवणायाद कोणत्याही डे टा चकंवा पररणामांच्या वापरास प्रचतबंचधत
4.
ि करण्यास सहमत आहे.
5. वरील अभ्यासात भाग र्ेण्यास मी सहमत आहे.
वरील संदचभदत अभ्यासाच्या कायदपद्धती आचण भेटींिी संख्या याबद्दल मला रुग्ण माचहती
6.
पिकात सचवस्तर माचहती दे ण्यात आली आहे.
7. मला संभाव्य जोखीम आचण फायद्यांबद्दल स्पष्ट् केले गेले आहे (रुग्ण माचहती पिकात).

रुग्णाची स्वाक्षरी/अांगठ्याचा ठसा: __________________________ तारीख:_______________

अन्वेर्काची स्वाक्षरी: ____________________________________ तारीख: ______________

हनष्पक्ष साक्षीदाराची स्वाक्षरी: _____________________________ तारीख: ______________

(हनरक्षर पी.टी.एस. च्या बाबतीत)

6
रुग्ण/चिष्पक्ष साक्षीदारािी स्वाक्षरी/अंगठ्यािा ठसा
(डु प्लिकेट मध्ये अंमलात आणूि त्यािी एक प्रत चवषयाला/रुग्णाला सुपूदद करणे)
 Food & Drugs Administration (Maharashtra State)
Letter No: MH/TZ2/PRP/1104658
Food & Drugs Administration, KONKAN Division
OFFICE OF JOINT COMMISSIONER [K.D]
Additional Product Permission 4TH FL.ESIC BLD,WAGLE ESTATE
Thane - 400604

705794- SHIVAYU AYURVED PERMISSION No : 1104658

M/S SHIVAYU AYURVED LTD.,84/114, TAWAKKAL LAYOUT,OFF KATOL ROAD
BYPASS,WADI,, NAGPUR -440023 (M.S.)PH NO. 9422113949, NAGPUR - 440023 Dt : 15/02/2023
Taluka: Nagpur Rural, District: NAGPUR ZONE 1

Ref :- Your Inward Application vide Inward ID :- 218515 Dated :- 28/12/2022

With reference to your Inward application,we have to inform you that your said application is considered &
following PRODUCTS PERMISSION have been granted, under the following LICENSES.
Type Form LIC No / Validity First Issue /
Rnw
L-AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (TZ2-Sona(701006) 25E MH/104900A 30/11/2022
K1 to K5, Rajlaxmi Sulzar Park,,Opp.Kripa Industrial Complex,Sonale - Bhiwandi - 421302 , Tal: ZONE6, 29/11/2027 30/11/2022
Dist: Thane-Zone2

Prod Name of Drugs

1. GALACT CAPSULE / CAPSULE (AYURVEDIC PROPRIETARY MEDICINE) Domestic (IHS(In House))
871857 Each Capsule contains dried extract derived from: - SHATAVARI (ASPARAGUS RACEMOSUS (Roots) (BP277) (In
House) (1500 mg)
- VIDARIKAND (PUERARIA TUBEROSA) (Tuber) (BP276) (In House)
(100 mg)
- SOWA (ANETHUM SOWA) (Seed) (BP34) (In House) (96 mg)
- GOKSHUR PANCHANG (TRIBULUS TERRESTRIS) (Fruits) (BP
239) (In House) (250 mg)
- YASHTIMADHU (GLYCYRRHIZA GLABRA) (Roots) (BP159)
100MG (In House) (100 mg)
- JEERA SAFED (CUMINUM CYMINUM) (Seed) (BP 144) (In House)
(100 mg)
- AHLIV(CHANDRASHUR) (LEPIDIUM SATIVUM) (Seed) (BP149) (In
House) (500 mg)
- EXCIPIENTS IP (Q.S. )
- METHYL PARABEN IP (- )
- PROPYL PARABEN IP (- )
2. GALACT GRANULES / GRANULES ( AYURVEDIC PROP. MEDICINE ) Domestic (IHS(In House))
871856 Each 100gm Contains extract derived from item No.1 to 6 & Powder - SHATAVARI ( ASPARAGUS RACEMOSUS ) (Roots) (BP 277 ) (In
of Item No.7: House) (15 GM)
- VIDARIKAND (PUERARIA TUBEROSA) (Tuber)(BP276) (In House)
(1 GM)
- SOWA (ANETHUM SOWA) (Seed) (BP34) (In House) (1 GM)
- GOKSHUR PANCHANG (TRIBULUS TERRESTRIS) (Fruits) (BP
239) (In House) (2.5 GM)
- YASHTIMADHU (GLYCYRRHIZA GLABRA) (Roots) (BP159) (In
House) (1 GM)
- JEERA SAFED (CUMINUM CYMINUM) (Seed) (BP 144) (In House)
(1 GM)
- AHLIV (CHANDRASHUR) (LEPIDIUM SATIVUM) (Seed) (BP149)
(In House) (1 GM)
- EXCIPIENTS ( Sugar+ Flavour) IP (Q.S. )
- METHYL PARABEN SODIUM IP (- )
- PROPYL PARABEN SODIUM IP (- )

Fee Payment(s) : DB-Id: 454009 - 28/12/2022 (Amt: 200) (Paid by E Payment) Balance : COL-Colour, FLV-Flavour,PRV-Preservative,REA-Reagent
100
This License/Certificate is eSIGNED. Physical Signature is NOT Required
Division MFG ID No Type:Additional Product Permission PERMISSION No Issue Date
KONKAN (TZ2) 705794 PRP-218515-28/12/2022 1104658 15/02/2023
For online Third Party Approval Verification;Go to fdamfg.maharashtra.gov.in & Click TPAV bu Pg: 1 / 2 (21/02/23) N I C
 Terms and Conditions
1) Licensee should comply with all the provisions of Drugs & Cosmetics Act, 1940 & Rules 1945 as amended up to dt.
2) Licensee should comply with all the provisions of Drugs (Price Control) Order 2013 as amended up to dt (wherever
applicable).
3) Licensee should abide by all the provisions of Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954 &
Rules 1955 as amended up to date
4) Licensee should not manufacture any drug/cosmetic by a name belonging to another manufacturer
5) Licensee should not manufacture or sell drugs/cosmetics even if it is included in the approved list of product, if it is or
as and when banned by Licensing Authority or Drugs Controller General of India or Government of India.
6) The permission is granted subject to the condition that, the product is safe, for use in context of pharmaceutical Aids,
Additions and excipient used in the formulation
7) Any addition thereto or any deletion therefore will not be carried out without permission of Licensing Authority

ADITI MOHAN KULKARNI ADITI MOHAN KULKARNI

e-Signed on 15-02-2023 16:04 State Licensing Authority
Food & Drugs Administration
TPAV # V1VI9I96SA KONKAN Division, Maharashtra State

Fee Payment(s) : DB-Id: 454009 - 28/12/2022 (Amt: 200) (Paid by E Payment) Balance : COL-Colour, FLV-Flavour,PRV-Preservative,REA-Reagent
100
This License/Certificate is eSIGNED. Physical Signature is NOT Required
Division MFG ID No Type:Additional Product Permission PERMISSION No Issue Date
KONKAN (TZ2) 705794 PRP-218515-28/12/2022 1104658 15/02/2023
For online Third Party Approval Verification;Go to fdamfg.maharashtra.gov.in & Click TPAV bu Pg: 2 / 2 (21/02/23) N I C
 Galact Capsule
Why Is There A Need of Galactagogue:

Mother's milk is considered as one of the most suitable supplements for the infant. Amid
the initial six months of kids' life, breast milk is the ideal source of nourishment for
them. Mother’s milk contains supplement proteins, non-protein nitrogen compounds,
enzymes, lipids, oligosaccharides, hormones, host defense agents, vitamins A, C, B,
lysozyme, antibodies, and in addition numerous different elements that assemble a solid
and healthy human being.

However, the emission of milk from the mammary organs is controlled, to a greater
extent by the concentration of prolactin. There is sufficient evidence now to support the
conviction that the prolactin hormone is straightforwardly in-charge for promotion of
milk secretion and that abnormally low levels of this hormone is characteristic of
deficient lactation in mothers.

A galactagogue is a substance that promotes lactation in humans and others.

Galactagogues are synthetic or plant molecules used to induce, maintain, and increase
milk production , which mediate complex processes involving interaction between
physical and physiological factors. They may be used to treat lactation failure.

Product Profile:
Galact Capsule is enriched with Shatavari. Shatavari, or Asparagus racemosus, has
been utilized for quite a long time as a part of Ayurveda to support the female

1|Page
reproductive system, and as a support for the digestive system, particularly in instances
of excess pitta. Deciphered as "having one hundred roots"(1,2). Shatavari's name offers
reference to its traditional use as a rejuvenate tonic for the female reproductive system.
This traditional tonic is also thought to aid in improving hormonal imbalances, ease the
transitions through various phases of life (including menopause), and acts as a natural
enhancer for breast milk production

Composition:
Each capsule contains aqueous extract derived from:
Shatavari (Asparagus racemosus) Roots -1500 mg
Vidarikanda (Pueraria tuberosa) Tuber– 100 mg
Sowa (Anethum sowa) Seed– 96 mg
Gokshur panchang (Tribulus terresteris) Fruits – 250 mg
Yashtimadhu (Glycyrrhiza glbra) Roots– 100 mg
Jeera safed (Cuminum cyminum) Seed – 100 mg
Ahliv ( Chandrashur) (Lepidium sativum) Seed – 500 mg
Sugar q.s

Summary of Product Characteristics (SPC):

Ayurvedic Properietory Medicine

Dosage & administration

Dosage form: Capsule

Route of Administration: Oral

Dose: As a herbal formulation for adults, take 1-2 Galact capsule twise daily with
milk or as directed by a healthcare practitioner

Indications:

● A Natural galactagogue and Promotes milk production in lactating mothers

● It improves the quality & quantity of milk
● Supports Maintenance of hormonal balance
● Supports menstrual cycle and hormonal balance

2|Page
Contraindications: Individuals who are sensitive to ingredients listed in the formula
should avoid consumption

Side Effects & Special Precautions: Being an herbal product no serious Drug
interaction & Side effects have been reported till date.

Overdose: An intake of 2-3 times more than the recommended dose is generally well
tolerated. In the event of intake greater than prescribed dose, skip the next dose. If
digestion discomforts occur, consult your healthcare practitioner

Storage: Store in a cool & dry place away from direct sunlight. Keep out of reach of
children

Shelf Life: 36 months from the date of manufacturing

Proposed Mechanism of Action of Galact Capsule:

Ingredients of Galact capsule is a known source of phytoestrogen, which can be effective

in reducing adverse menopausal symptoms. Studies further suggest that Shatavari, one
of the most important ingredients in the formulation stimulates the pituitary gland and
ACTH, resulting in the secretion of prolactin, which is essential for the synthesis of milk
in the mammary glands (3). It is also believed to exert a strong anti-oxytocin effect,
thereby strengthening prolactin levels for lacto-genesis.

Another proposed mechanism of action is related to phyto-estrogens. It is thought that

phyto-estrogen molecules in Shatavari act upon pituitary lacto-trophic cells and
mammary epithelial cells to increase the secretion of prolactin. Lastly, Shatavari
contains steroidal saponins, which have been scientifically recognized for its
galactogogue action (4).

Individual Ingredients:

Vidarikanda ( Pueraria tuberosa )

Vidarikanda (Pueraria tuberosa ) is one among the ingredients in many formulations
used for the management of low milk production in females. Traditional ayurvedic
literature shows that Pueraria tuberosa is associated with milk and sugar increases the
breast milk [6] . Clinical study designed to evaluate the lactogenic activity of Pueraria
tuberosa shows improvement in the parameters like weight of the baby breast
engorgement, milk ejection, and highly increased serum prolactin level. (7)

3|Page
Sowa( Anethum sowa) :
Anethum sowa is a well-known galactagogue that is known to increase the flow of milk in
nursing mothers and will then be taken by the baby in the milk to help prevent colic (10).

Gokshur panchang ( Tribulus terrestris ) :

Its roots and fruits are diuretic, aphrodisiac, appetiser, digestive and tonic. It exhibits
spasmogenic, analgesic, muscle relaxant activity. It also has antimicrobial, antifungal,
antibacterial property. Patitients treated with a herbomineral combination containing
gokshur as one of the ingredients showed its marked diuretic and antiurolithiatic
property.

Yashtimadhu ( Glycyrrhiza glabra ) :

Glycyrrhiza glabra L is known for its powerful antioxidant activity because of its
significant free radical scavenging, hydrogen-donating, metal ion chelating, anti-lipid
peroxidative and reducing abilities. Antioxidant activity of liquorice flavonoids was
found to be over 100 times stronger than that of antioxidant activity of vitamin E (5).
Thus, liquorice can be efficiently used to formulate various formulations for the
protection of cells producing hormones against oxidative damage.

Jeera safed ( Cuminum cyminum ) :

Cumin (Cuminum cyminum) seed contains a volatile oil that contains cuminaldehyde
and other aldehydes; the seeds also contain numerous flavonoids and terpenes. Cumin
has been used as a galactogogue in India. Cumin is a known galactagogue and for its
galactopoiesis property. The addition of cumin seed to the formulation significantly
enhanced milk production by 13% as compared to the control group (8)

Ahliv ( Chandrashur) ( Lepidium sativum )

Studies have shown that supplementation with Lepidium sativum caused significant
increase in the milk yield in animals. This effect of Lepidium sativum is dose dependent
where increase in the dose of the active ingredient showed increase in the milk
production. The probable mechanism due to which the increase in the milk yield in the
animal can be related to higher amount of nutrient utilization and its availability for

4|Page
milk synthesis (9)

References:

1.Pole, Sebastian. Ayurvedic Medicine: The Principles of Traditional Practice. Churchill

ivingston; 2006. 271-272.

2.Simon, David and Deepak Chopra. The Chopra Center Herbal Handbook. Three Rivers
Press, New York; 2000. 73-75.

3. Behera, P. C., Tripathy, D. P., & Parija, S. C. (2012). Shatavari: Potentials for
galactogogue in dairy cows. IJTK Vol.12(1) [January 2013]
4. A Double-Blind Randomized Clinical Trial for Evaluation of Galactogogue Activity of
Asparagus racemosus Willd. Mradu Gupta and Badri Shaw

5. Damle, M. (2014). Glycyrrhiza glabra (Liquorice) - a potent medicinal herb.

International Journal of Herbal Medicine, 2(2), 132–136.
https://www.florajournal.com/archives/2014/vol2issue2/PartC/23.1.pdf

6. Dr. Asha Kumara, Dr. KM. Premvati Tiwari, A complete tretice on Ayurveda
Yogaratnakara, first edition Varanasi, 2010, 1170.

7. S, C., S, P., & Paul, R. P. (2018). Lactogenic activity of selected medicinal plants: A
review. Journal of Pharmacognosy and Phytochemistry, 8(5), 2479–2482.
https://www.phytojournal.com/archives/2019/vol8issue5/PartAS/8-5-11-489.pdf

8. Patil, A., Baghel, R., Nayak, S., Malapure, C., Govil, K., Kumar, D., & Yadav, P. K.
(2017). Cumin (Cuminum cyminum): As a Feed Additive for Livestock. Journal of
Entomology and Zoology Studies, 5(3), 365–369.
https://www.entomoljournal.com/archives/2017/vol5issue3/PartF/5-2-144-619.pdf

9. Kumar, S., Baghel, R., & Khare, A. (2010). EFFECT OF CHANDRASOOR (Lepidium
sativum) SUPPLEMENTATION ON DRY MATTER INTAKE, BODY WEIGHT AND
MILK YIELD IN LACTATING MURRAH BUFFALOES. Buffalo Bulletin, 30(4), 262–
266. http://ibic.lib.ku.ac.th/e-Bulletin/IBBU201104009.pdf

10. Kaur, G., & Arora, D. S. (2010). Bioactive potential of Anethum graveolens,
Foeniculum vulgare and Trachyspermum ammi belonging to the family Umbelliferae -
current status. Journal of Medicinal Plants Research, 4(2), 087–094.
https://doi.org/10.5897/jmpr09.018

5|Page
 Open Access Original
Article DOI: 10.7759/cureus.26831

Postpartum Use of Shavari Bar® Improves Breast

Milk Output: A Double-Blind, Prospective,
Review began 07/03/2022
Randomized, Controlled Clinical Study
Review ended 07/11/2022
Published 07/13/2022 Amita Birla 1 , Meena Satia 2 , Rita Shah 3 , Arnav Pai 4 , Shruti Srivastava 4 , Deepak Langade 5

© Copyright 2022
Birla et al. This is an open access article 1. Clinical Research, Act Lifesciences Pvt Ltd., Navi Mumbai, IND 2. Obstetrics and Gynecology, Dr. DY Patil Hospital
distributed under the terms of the Creative and Research Centre, Navi Mumbai, IND 3. Prenatal and Postnatal Care, NM Medical Center, Mumbai, IND 4.
Commons Attribution License CC-BY 4.0., Gynecology, Dr. DY Patil Hospital and Research Centre, Navi Mumbai, IND 5. Pharmacology, Dr. DY Patil University,
which permits unrestricted use, distribution, School of Medicine, Navi Mumbai, IND
and reproduction in any medium, provided
the original author and source are credited.
Corresponding author: Amita Birla, [email protected]

Abstract
Background and objectives
Appropriate nutrition, along with the establishment of lactation, is of paramount importance for the feeding
mother and the growing neonate. Asparagus racemosus, a common name for Shatavari, is a well-known herb
that has been used as a galactagogue in traditional Indian culture. It is also referenced in Ayurvedic
medicine. Despite multiple formulations available, palatability has been a concern always as Shatavari is
very bitter. We have devised a palatable and nutritionally rich formulation of Shatavari with no artificial
ingredients. To understand the efficacy, we have conducted this double-blind, prospective, randomized,
controlled study to evaluate the effect of oral Shatavari formulation (Shavari Bar®) on breast milk output in
postpartum women.

Methods
A prospective, randomized, parallel-group, double-blind, placebo-controlled study was conducted at two
centers in women with gestational age 37 weeks or more who intended to breastfeed. Hundred and four
women were screened, of which 78 were randomized to receive either bar containing Shatavari and oats
(n=39, study) or an identical placebo bar (n=39, control). All 78 women completed the study, 61 delivered by
a lower segment Caesarean section (LSCS), and 17 had a full-term normal vaginal delivery. Time to first
noticeable breast fullness was measured and expressed milk volume measurements were done 72 hours after
delivery or after consumption of four bars, whichever was later using a standardized breast pump.
Comparison between the two groups was analyzed using a t-test.

Results
Demography and baseline data of patients enrolled were similar in the two groups. The mean total milk
volume expressed was higher (p=0.008) with Shavari (64.74 ml) compared to placebo (49.69 ml). The time to
breast fullness was shorter (p=0.024) with Shavari (30.49 hours) compared to placebo (38.09 hours). No
adverse events were noted in either of the study groups. Global assessment of the satisfaction of mothers
with lactation, the well-being of the child, taste, and ease of use was better in the treatment arm than in the
placebo arm.

Conclusion
The use of the Shavari bar can be an effective option in postpartum women to establish early lactation and
build confidence in breastfeeding along with nonpharmacological intervention.

Categories: Obstetrics/Gynecology, Pediatrics, Nutrition

Keywords: asparagus racemosus, shavari bar, post-partum nutrition, breast-feeding, lactation, shatavari

Introduction
Breast milk provides the ideal nutrition for the infant, and World Health Organization (WHO) recommends
exclusive breastfeeding for the initial six months. Breastfeeding is one of the most effective ways to ensure
child health and survival. Adequate milk production is not only critical, but the initial early milk production
has been shown to significantly affect milk production during the established lactation phase. However,
nearly two out of three infants are not exclusively breastfed for the recommended six months, a rate that has
surprisingly not improved in two decades despite multiple educational initiatives by the healthcare
professional (HCP) community [1]. Many women express concern about their ability to produce enough
milk, and insufficient milk production has been cited as a reason for supplementation and early cessation of
breastfeeding [2].

How to cite this article

Birla A, Satia M, Shah R, et al. (July 13, 2022) Postpartum Use of Shavari Bar® Improves Breast Milk Output: A Double-Blind, Prospective,
Randomized, Controlled Clinical Study. Cureus 14(7): e26831. DOI 10.7759/cureus.26831
 A longitudinal observational study that enrolled mothers who had initiated breastfeeding after delivering
healthy-term infants found that the rate of discontinuation of breastfeeding was nearly 37% by week two
[3]. There was a high frequency of concerns about inadequate milk production in early lactation which led to
the introduction of water or top feeds in the initial postpartum days. If supplementary feeds were given
instead of breastfeeds, they might have a negative impact on milk supply. Adequate milk supply in the first
few weeks postpartum is critical, and nonpharmacological interventions are commonly practiced, like skin-
to-skin contact, breastfeeding within an hour of birth, and frequent breastfeeding during the first 24 hours
after birth [4]. Oral galactagogues, substances that stimulate milk production, may be used to improve breast
milk output.

Shatavari (Asparagus racemosus), also known as "wild asparagus", is a plant native to the Indian
subcontinent and used in Ayurvedic medicine. It has a long history of use as a galactagogue in India and is
also included in the official ayurvedic pharmacopeia for this use [5]. The primary active constituents of A.
racemosus are steroidal saponins found in the roots [5]. It is loaded with folic acid, vitamins A, C, and K, and
phytoestrogens; the hormonal effect of phytoestrogens is like estrogen in milk production. A key regulator
of prolactin production is estrogens which enhance the growth of prolactin-producing cells and stimulate
prolactin production directly, as well as by suppressing dopamine. It also contains tryptophan, an essential
amino acid that may stimulate prolactin production, leading to increased milk production [6].

Shatavari is available in various forms like powder, granules, capsules, etc. However, many of these
formulations use a very high sugar content to mask the bitter taste of Shatavari. Also, most of these
products must be mixed with milk, so the palatability and taste are of concern. We have developed a unique
formulation of Shatavari, Shavari Bar®, which is a granola bar having Shatavari and oats along with dry
fruits, honey, and sweetened cocoa. It is natural and preservative-free. This study was conducted to evaluate
the product's efficacy and safety, and palatability in the postpartum phase for breastfeeding mothers.

Materials And Methods

Objectives
This study evaluated the efficacy and safety of oral administration of Shavari Bar® versus placebo bar in
increasing breast milk output during the postpartum period.

Study design and setting

The prospective, randomized, parallel-group, double-blind, placebo-controlled study was conducted at two
obstetric settings, DY Patil Hospital in Navi Mumbai and NM Medical Center in Mumbai. Following the
international mandate, the study protocol was designed per the Declaration of Helsinki developed by the
World Medical Association (2013 amendment). The Institutional Ethics Committee approved the study
protocol and documents, DY Patil Medical College and Hospital, Navi Mumbai (No. DYP/EC/15/2021; July 9,
2021) and registered with the clinical trials registry of India (CTRI/2021/08/035753; August 18, 2021). The
study was conducted in accordance with the Good Clinical Practice (GCP) guidelines and informed written
consent was obtained from all participants before starting any study-related procedures. The study was
conducted between August 2021 and May 2022. The entire study was conducted and reported following the
Consolidated Standard of Reporting Trials (CONSORT) statement.

Study participants
Pregnant women with the gestational age of 37 weeks or more who intend to breastfeed were invited to
participate in this study. Women who delivered by vaginal delivery or lower segment Cesarean section (LSCS)
delivery were enrolled.

Inclusion Criteria

Healthy women between 20-40 years of age who signed informed consent, with uncomplicated full-term
delivery (vaginal or LSCS), women who have accomplished antenatal breastfeeding promotion protocol
immediately postpartum or within three days of delivery, and women able to understand the study
requirements and can fill the study log diary, and follow other procedures required by the study protocol
were enrolled.

Exclusion Criteria

Postpartum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs,

radioactive substances, and babies with galactosemia, were excluded. Postpartum women with unstable
conditions (i.e., postpartum hemorrhage, sepsis). Women with known allergies to Shatavari or oats, raisins,
almonds, cocoa, and honey were excluded. Women whose babies require phototherapy, women with
insufficient glandular tissue or breast surgery and any structural abnormality of the breast were excluded.
Women with a history of infertility, hypothyroidism, women with twins, or higher-order births were
excluded. Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular,

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 gastrointestinal, respiratory, hematological, or neurological illnesses or the presence of any current
psychiatric disorders in women were considered as exclusion criteria. If any other investigational drug was
used within three months before the entry in this study or those who cannot be relied upon to comply with
the test procedures or are unwilling to give informed consent were excluded from the study.

Sample size, randomization, and blinding

It was planned to enroll 80 subjects in this exploratory study with a randomization ratio of 1:1.
Randomization was done using a computer-based pre-determined randomization program (Rando Version
1.0) in a block of 20. Thus, there were four blocks of 20 in each, with each block containing 10 patients in the
study group and 10 in the control group. Both patients and study group members, who conducted and
assessed the outcomes, were unaware of the treatment received by the women. Blinding was done by
preparation of a placebo bar that was identical in size, shape, color, and taste to the Shavari bar. The
packaging was labeled to conceal the contents of the packet. Women who qualified for the study during
screening were allocated a serial number in a sequence, and the women received the treatment packet based
on the serial number (study number) allocated to the patient. The randomization codes were maintained in
separate sealed envelopes accessible only to the principal investigator in an emergency.

Study outcomes
The primary outcome was the total volume (ml) of breast milk produced on the third postpartum day (72
hours after delivery) or after taking four doses of the study medication, whichever is later, during 15 minutes
of pumping both breasts using a breast pump/manually two hours after breastfeeding.

Secondary efficacy outcomes were: i) time to noticeable breast fullness after delivery; ii) subjective
satisfaction of mother regarding the well-being and happiness of newborn; iii) subjective satisfaction of
mothers regarding the state of lactation; iv) subjective satisfaction of investigator regarding the well-being
of the mother, and v) subjective satisfaction of investigator regarding the well-being of the newborn.
Secondary safety outcomes were: i) proportion of patients experiencing treatment-emergent adverse events
(TEAEs), and ii) subjective satisfaction of patients with the taste and ease of use of the product. All
subjective assessments were assessed on a five-point Likert scale (very satisfied, satisfied, neutral,
unsatisfied, very unsatisfied).

Safety was assessed based on the spontaneous reports generated by the patients/clinicians. All adverse
events (AEs) and serious adverse events (SAEs) were reported as per local regulatory guidelines.

Interventions
Control Group (Placebo): Group A

The control group received a placebo formulation (bar containing oats, dry fruits, honey, and chocolate-
flavored) not containing Shatavari. The placebo bar was identical in size, shape, and appearance to the study
formulation (Shavari Bar®). Women continued their routine postpartum care as per the hospital protocol.

Study Group: Group B

The study group received oral supplementation with the study product (Shavari Bar®) for five days, starting
on day two after delivery (the first postpartum day). Shavari Bar® contained Shatavari, oats, dry fruits, and
honey and was chocolate flavored. Women continued their routine postpartum care as per the hospital
protocol. Figure 1 presents the CONSORT flowchart for patients in the study.

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 FIGURE 1: CONSORT flowchart
CONSORT - Consolidated Standard of Reporting Trials

Study procedures
Informed Consent

Informed consent was obtained before starting any study-related procedures on the patients.

Clinical and Physical Examinations

All participants underwent a complete clinical examination on enrolment to rule out any abnormalities. The
medical history of all the women was taken before study initiation. Vital parameters were reported (pulse,
blood pressure, temperature, and respiratory rate). Women underwent general and systemic examinations
(cardiovascular, respiratory, abdominal, nervous, and musculoskeletal systems).

Time to Noticeable Breast Fullness

Time to evident breast fullness is defined as the mean time from birth to evident breast fullness. The
participants were asked if they noticed their breasts were full, followed by the question: "When did you feel
breast fullness?".

Milk Volume Measurements

Milk volume was measured after the breast milk expression from both breasts using a breast pump. An
electric breast pump with three-phase pumping, which includes massage, stimulation, and expression, was
used. Manual extraction was done in case of failure to use a breast pump.

Subjective Satisfaction

Subjective assessment for satisfaction by mothers regarding the well-being and happiness of babies and the
state of lactation were assessed on a five-point Likert scale: very satisfied, satisfied, neutral (neither
satisfied nor dissatisfied), unsatisfied, very unsatisfied. Subjective satisfaction of the investigator was
assessed on a five-point Likert scale, as noted above. Subjective satisfaction of patients on the taste and ease
of use of the product was on a five-point Likert scale, as noted above.

Compliance

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 Women were asked to maintain a log for study medication for medication compliance.

Safety Assessment

Clinical safety was assessed by evaluating adverse events reported and/or observed during the study. The
patients reported adverse events during the follow-up or the clinical evaluation of patients.

Results
The complete set of data was analyzed, and also LSCS and normal delivery subgroup analysis was carried
out. In the total study population, 61 patients had undergone LSCS, and 17 were normal delivery patients.
The demographic baseline data of both arm A and arm B were comparable in terms of age, height, weight,
and body mass index (BMI). Vitals like pulse, blood pressure, and temperature are presented in Table 1.

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 Control group (placebo) Study group (Shavari Bar®) t-test
Data
N Mean SD N Mean SD p

LSCS delivery (n=61)

Age (years) 31 29.19 5.69 30 28.93 3.22 0.827

BMI (kg/m2 ) 31 28.78 3.91 30 29.19 4.28 0.698

SBP (mm Hg) 31 118.32 8.53 30 116.87 8.03 0.496

DBP (mm Hg) 31 75.87 5.11 30 74.93 4.81 0.464

Pulse rate (per min.) 31 81.81 8.72 30 82.07 8.95 0.909

Temperature (F) 31 96.65 1.32 30 96.79 1.31 0.750

Time after starting drug (hours) 31 70.03 1.92 30 71 2.29 0.079

FTND (n=17)

Age (years) 8 28.5 2.62 9 27.44 3.47 0.494

Height (cm) 8 155 4.24 9 147.67 24.67 0.421

Weight (kg) 8 71.38 17.56 9 74.4 11.56 0.677

BMI (kg/m2 ) 8 29.63 6.67 9 37.32 16.21 0.231

SBP (mm Hg) 8 115.75 4.83 9 116.67 6.16 0.740

DBP (mm Hg) 8 77 4.41 9 75.78 5.14 0.609

Pulse rate (per min.) 8 85.25 6.58 9 74.22 25.39 0.253

Temperature (F) 8 97.3 0.79 9 97.53 0.12 0.636

Time after starting drug (hours) 8 70.75 2.05 9 70.78 2.73 0.982

All patients (n=78)

Age (years) 39 29.05 5.19 39 28.59 3.29 0.640

Height (cm) 39 157.54 8.43 39 153.03 12.72 0.069

Weight (kg) 39 71.74 11.82 39 70.93 11.5 0.758

BMI (kg/m2 ) 39 28.95 4.51 39 31.06 9.02 0.195

SBP (mm Hg) 39 117.79 7.93 39 116.82 7.56 0.580

DBP (mm Hg) 39 76.1 4.94 39 75.13 4.83 0.381

Pulse rate (per minute) 39 82.51 8.37 39 80.26 14.42 0.401

Temperature (F) 28 96.83 1.22 17 96.92 1.21 0.808

Time after starting drug (hours) 39 70.18 1.94 39 70.95 2.36 0.121

TABLE 1: Demography and baseline data of patients enrolled

BMI - body mass index; DBP - diastolic blood pressure; FTND - full-term normal delivery; LSCS - lower segment Caesarean section; SBP - systolic blood
pressure

There was a significant increase in total volume (ml) of breast milk produced on the third postpartum day
(72 hours after delivery) or taking four doses of the study medication, whichever is later, measured after
breast milk expression from both breasts using a breast pump. An electric breast pump with three-phase
pumping, which includes massage, stimulation, and expression, was used for 15 minutes of pumping both
breasts two hours after breastfeeding. Similarly, the time to breast fullness was much lesser in the treatment
arm as compared to the placebo arm. The time to breast fullness was 38.09 hours and 30.49 hours,
respectively, in the placebo vs. treatment arm, and milk volumes were 49.69 ml and 64.74 ml, respectively,

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 in the placebo vs. treatment arm. The volume increase was seen in both normal delivery and the LSCS
groups. In the LSCS group, time to breast fullness was 40.65 hours and 32.2 hours, respectively, in the
placebo vs. treatment arm and milk volumes were 52.35 ml and 66.67 ml, respectively, in the placebo vs.
treatment arm. In the full-term normal delivery (FTND) group, time to breast fullness was 28.19 hours and
24.78 hours, respectively, in the placebo vs. treatment arm and milk volumes were 39.38 ml and 58.33 ml,
respectively (Table 2).

Control group (placebo) Study group (Shavari Bar®) t-test

Breast fullness and milk volume
N Mean SD N Mean SD p

LSCS delivery (n=61)

Time to breast fullness (hours) 31 40.65 17.08 30 32.2 12.55 0.032

Total milk volume (ml) 31 52.35 24.72 30 66.67 25.2 0.029

FTND (n=17)

Time to breast fullness (hours) 8 28.19 11.08 9 24.78 8.06 0.475

Total milk volume (ml) 8 39.38 27.44 9 58.33 13.23 0.084

All patients (n=78)

Time to breast fullness (hours) 39 38.09 16.7 39 30.49 12 0.024

Total milk volume (ml) 39 49.69 25.48 39 64.74 23.11 0.008

TABLE 2: Time to breast fullness and milk volume extracted after 72 hours after delivery
FTND - full-term normal delivery; LSCD - lower segment Caesarean section

In the global assessment of the satisfaction of mothers with lactation and the well-being of children in the
treatment arm, 85% of mothers were satisfied to very satisfied, and in the placebo arm, this was 74% (Figure
2).

FIGURE 2: Satisfaction of mother with lactation and well being

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 Similarly, in the global assessment of the satisfaction of doctors with lactation and well-being in the
treatment arm, 87% of doctors were satisfied to very satisfied, and in the placebo arm, this was 69% (Figure
3).

FIGURE 3: Satisfaction of doctor with lactation and well being

Satisfaction of mothers with taste and ease of use in the treatment arm, 95% of mothers were satisfied to
very satisfied, and in the placebo arm, this was 72% (Figure 4).

FIGURE 4: Satisfaction of mother with taste and ease of use

No adverse events were reported.

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 Discussion
Many women face the concern of insufficient milk production, which leads to supplementation and early
termination of breastfeeding. Non-pharmacological treatment in such women needs consideration for the
influence of various maternal and neonatal factors like the baby's sucking and latching with the breast, and
feeding frequency on milk production. Oral galactagogues are substances that stimulate milk production
and are frequently used for improving breast milk output.

Breast milk provides the ideal nutrition for the infant, and WHO recommends exclusive breastfeeding for the
first six months. Many women express concern about their ability to produce enough milk, and insufficient
milk is frequently cited as the reason for supplementation and early termination of breastfeeding [2]. A
longitudinal observational study that enrolled mothers who initiated breastfeeding after delivering healthy-
term infants found that the rate of discontinuation of breastfeeding was 37% by the second week [3]. Mothers
suffer from a feeling of failure and inferiority when they cannot produce sufficient milk for their babies.
Despite all the knowledge and guidelines, it is still a common problem, and top feeds are given early
postpartum due to insufficient breast milk production.

There is a high frequency of inadequate milk production in early lactation, which leads to the introduction
of water or top feeds in the first few days after delivery. If top feeds are given instead of breastfeeds, it could
have a negative impact on breast milk production. Milk supply in the first postpartum week is of critical
importance. In the current study, two important parameters were accessed. The time to breast fullness was
reduced in the treatment arm, and the quantity of milk produced increased. Early achievement of breast
milk production can have a positive impact on the confidence of the mother and lead to continued efforts
for breastfeeding.

Health care providers rely on non-pharmacological interventions and usually are in a dilemma as many
galactagogues are not backed up with robust evidence. Given the suboptimal rates of exclusive breastfeeding
and the availability and demand for medical and herbal lactation therapies, controlled trials and analyses
investigating these medicines are urgently warranted [7]. So, we conducted this randomized, double-blind
clinical study on the Shavari bar.

Our findings indicate that the Shavari bar increases breast milk production in nursing mothers more
effectively than a placebo. A statistically significant increase in breast milk volume was observed in the
study arm. It is worth noting that most of the subjects enrolled had undergone LSCS. Mothers undergoing
LSCS are less prone to breastfeeding and tend to delay breastfeeding initiation [8]. This was also observed in
placebo arms of the study, where there was significant variation in time to breast fullness among LSCS and
vaginal delivery placebo subgroups. The study arm showed a significant increase in milk volume.
Importantly, no maternal or neonatal adverse events were observed in the study. The use of pharmacological
galactagogues has been associated with side effects.

Also, this study found that Shavari bars reduce time to breast fullness and can help establish lactation early,
which can avoid the introduction of water and top feeds and benefit the mother and neonate. Another
strength of the current study was that it was a randomized placebo-controlled study regarded as higher
quality evidence. The measurement of milk for most patients was taken in a hospital setting using a
standard breast pump, so data variability was less, and variation due to differences in the method of milk
extraction was less.

In the current study, the treatment with Shavari bars resulted in a statistically significant and clinically
meaningful increase in milk production. This was in line with an earlier randomized, double-blind clinical
study of Shatavari. The galactagogue effect of Shatavari was evaluated in 60 mothers by recording changes
in their prolactin hormone levels [9]. The Shatavari group showed a more than three-fold increase in the
prolactin hormone level compared to the control group. There was a substantial increase in the weight of the
babies in the study group. Subjective satisfaction of the mother regarding the state of lactation and the well-
being and happiness of the child was many folds more in the Shatavari group.

Compliance is again a very important aspect. Shatavari is available in various oral dosage forms like powder,
granules, capsules, etc. However, many of these formulations have a very high content of sugar to mask the
bitter taste of Shatavari. Also, most of these products have to be mixed with milk, so the palatability and
taste are of concern. Shavari bar, the formulation that has been tested in the current study, is a granola bar
having Shatavari and oats along with dry fruits, honey, and sweetened cocoa. It is natural and preservative-
free. The study data showed that most of the patients gave satisfactory feedback about the taste. The global
feedback in the treatment arm was better than in the placebo arm.

Our study had certain drawbacks. The sample size was small. The time to breast fullness was not found to be
statistically significant among women with FTND in Shavari arm vs. placebo arm, possibly due to the smaller
sample size. There was a statistically significant increase in the amount of milk produced in Shavari arm vs.
the placebo arm (p<0.01); however, the same was not seen in the subgroup analysis, also possibly due to the
smaller sample size. The data on Shatavari needs to be generated in a bigger sample size. Also, there was no

2022 Birla et al. Cureus 14(7): e26831. DOI 10.7759/cureus.26831 9 of 10

 measurement of the blood level of prolactin to correlate with the clinical findings.

Conclusions
The most crucial period for success or failure of breastfeeding is the first ten days after delivery, which is also
the most stressful period for mothers. Perceived milk insufficiency is the major impediment as it leads to
true milk insufficiency. It leads to a vicious cycle of top feeds, decreased sucking, and low milk production.
Breastfeeding is almost universally started but is stopped very soon due to this myth; therefore, it is
necessary to have various interventions to support breastfeeding in the initial few days postpartum. The
current study supports the consideration of using the Shavari Bar® as an effective option to support women
in the first few days of the postpartum period to establish lactation and build confidence in breastfeeding
along with nonpharmacological intervention.

Additional Information
Disclosures
Human subjects: Consent was obtained or waived by all participants in this study. Dr. DY Patil Medical
College, Navi Mumbai issued approval DYP/EC/15/2021. Animal subjects: All authors have confirmed that
this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE
uniform disclosure form, all authors declare the following: Payment/services info: All authors have
declared that no financial support was received from any organization for the submitted work. Financial
relationships: All authors have declared that they have no financial relationships at present or within the
previous three years with any organizations that might have an interest in the submitted work. Other
relationships: All authors have declared that there are no other relationships or activities that could appear
to have influenced the submitted work.

Acknowledgements
We acknowledge Act Lifesciences Pvt Ltd. for providing Shavari Bars® and placebos.

References
1. WHO: breastfeeding. (2022). Accessed: May 24, 2022: https://www.who.int/health-
topics/breastfeeding#tab=tab_1.
2. Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH: Oral galactagogues (natural therapies or drugs)
for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst
Rev. 2020, 5:CD011505. 10.1002/14651858.CD011505.pub2
3. Ertem IO, Votto N, Leventhal JM: The timing and predictors of the early termination of breastfeeding .
Pediatrics. 2001, 107:543-8. 10.1542/peds.107.3.543
4. Kent JC, Gardner H, Geddes DT: Breastmilk production in the first 4 weeks after birth of term infants .
Nutrients. 2016, 8:1-6. 10.3390/nu8120756
5. Alok S, Jain SK, Verma A, Kumar M, Mahor A, Sabharwal M: Plant profile, phytochemistry and
pharmacology of Asparagus racemosus (Shatavari): a review. Asian Pac J Trop Dis. 2013, 3:242-51.
10.1016/S2222-1808(13)60049-3
6. Hajela R: Understand lactation and lactation failure: fight the curse of insufficient breast milk . Sch J Appl
Med Sci. 2015, 3:3289-301.
7. Bazzano AN, Hofer R, Thibeau S, Gillispie V, Jacobs M, Theall KP: A review of herbal and pharmaceutical
galactagogues for breast-feeding. Ochsner J. 2016, 16:511-24.
8. Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC: The impact of caesarean section on
breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy
Childbirth. 2016, 16:90. 10.1186/s12884-016-0876-1
9. Gupta M, Shaw B: A double-blind randomized clinical trial for evaluation of galactogogue activity of
asparagus racemosus willd. Iran J Pharm Res. 2011, 10:167-72.

2022 Birla et al. Cureus 14(7): e26831. DOI 10.7759/cureus.26831 10 of 10

PLOS ONE

RESEARCH ARTICLE

Use and experiences of galactagogues while

breastfeeding among Australian women
Grace M. McBride ID1,2,3, Robyn Stevenson1, Gabriella Zizzo1, Alice R. Rumbold1,2,3, Lisa
H. Amir4,5, Amy K. Keir1,2,3, Luke E. Grzeskowiak1,2,3,6,7*
1 Adelaide Medical School, University of Adelaide, Adelaide, Australia, 2 The Robinson Research Institute,
University of Adelaide, Adelaide, Australia, 3 South Australian Health and Medical Research Institute,
Adelaide, Australia, 4 Judith Lumley Centre, La Trobe University, Melbourne, Australia, 5 Breastfeeding
Service, Royal Women’s Hospital, Parkville, Australia, 6 SA Pharmacy, SA Health, Adelaide, Australia,
7 Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia
a1111111111
a1111111111 * [email protected]
a1111111111
a1111111111
a1111111111 Abstract

Background
OPEN ACCESS
Galactagogues are substances thought to increase breast milk production, however evi-
Citation: McBride GM, Stevenson R, Zizzo G, dence to support their efficacy and safety remain limited. We undertook a survey among
Rumbold AR, Amir LH, Keir AK, et al. (2021) Use
Australian women to examine patterns of use of galactagogues and perceptions regarding
and experiences of galactagogues while
breastfeeding among Australian women. PLoS their safety and effectiveness.
ONE 16(7): e0254049. https://doi.org/10.1371/
journal.pone.0254049
Methods
Editor: Jane Anne Scott, Curtin University,
AUSTRALIA An online, cross-sectional survey was distributed between September and December 2019
via national breastfeeding and preterm birth support organisations, and networks of several
Received: May 4, 2021
research institutions in Australia. Women were eligible to participate if they lived in Australia
Accepted: June 19, 2021
and were currently/previously breastfeeding. The survey included questions about galacta-
Published: July 1, 2021 gogue use (including duration and timing), side effects and perceived effectiveness (on a
Peer Review History: PLOS recognizes the scale of 1 [Not at all effective] to 5 [Extremely effective]).
benefits of transparency in the peer review
process; therefore, we enable the publication of
all of the content of peer review and author Results
responses alongside final, published articles. The
Among 1876 respondents, 1120 (60%) reported using one or more galactagogues. Women
editorial history of this article is available here:
https://doi.org/10.1371/journal.pone.0254049
were 31.5 ± 4.8 years (mean ± standard deviation) at their most recent birth. Sixty-five per-
cent of women were currently breastfeeding at the time of the survey. The most commonly
Copyright: © 2021 McBride et al. This is an open
access article distributed under the terms of the
reported galactagogues included lactation cookies (47%), brewer’s yeast (32%), fenugreek
Creative Commons Attribution License, which (22%) and domperidone (19%). The mean duration of use for each galactagogue ranged
permits unrestricted use, distribution, and from 2 to 20 weeks. Approximately 1 in 6 women reported commencing galactagogues
reproduction in any medium, provided the original
within the first week postpartum. Most women reported receiving recommendations to use
author and source are credited.
herbal/dietary galactagogues from the internet (38%) or friends (25%), whereas pharmaceu-
Data Availability Statement: Data cannot be
tical galactagogues were most commonly prescribed by General Practitioners (72%). The
shared publicly because the ethics committee
restricts secondary use of the data currently. Data perceived effectiveness varied greatly across galactagogues. Perceived effectiveness was
are available from The University of Adelaide highest for domperidone (mean rating of 3.3 compared with 2.0 to 3.0 among other

PLOS ONE | https://doi.org/10.1371/journal.pone.0254049 July 1, 2021 1 / 15

PLOS ONE Use of galactagogues while breastfeeeding

Human Research Ethics Committee (contact T: +61 galactagogues). Over 23% of domperidone users reported experiencing multiple side
8 8313 5137 | F: +61 8 8313 3700 | research. effects, compared to an average of 3% of women taking herbal galactagogues.
[email protected]) for researchers who
meet the criteria for access to confidential data.
Conclusions
Funding: GM was supported by an Australian
Government Research Training Program This survey demonstrates that galactagogues use is common in Australia. Further research
Scholarship. AK was supported by a National is needed to generate robust evidence about galactagogues’ efficacy and safety to support
Health and Medical Research Council Early Career
evidence-based strategies and improve breastfeeding outcomes.
Fellowship (GNT1161379). LG receives salary
support through a Mid-Career Research Fellowship
provided by The Hospital Research Foundation (C-
MCF-10-2019). LA, AR, GZ and LG were awarded a
Robinson Research Institute Engaging
Opportunities Grant 2019. The funders had no role
Introduction
in study design, data collection and analysis,
decision to publish, or preparation of the Breastfeeding is widely recognised to promote lifelong health for both the mother and infant
manuscript. [1]. International recommendations are exclusive breastfeeding until six months of age, with
Competing interests: The authors have declared ongoing breastfeeding for two years or longer [2, 3]. In Australia, evidence indicates that the
that no competing interests exist. majority of women initiate breastfeeding at birth; however, by six months of age, only 60% are
providing any breast milk, and 16% are exclusively breastfeeding [4]. This marked drop in
exclusive breastfeeding has been observed in many other high-income countries [5]. Previous
research shows that lactation insufficiency (also referred to as low breast milk supply), whether
real or perceived, is one of the most common reasons women discontinue breastfeeding [6, 7].
Lactation insufficiency can be caused by several factors, including insufficient mammary tis-
sue, irregular hormone levels, and ineffective milk removal from the breast [8].
The first-line management of lactation insufficiency involves non-pharmacological inter-
ventions, such as ensuring correct infant positioning and attachment [8, 9]. Where lactation
insufficiency persists, galactagogues—the term used to describe substances thought to promote
or increase breast milk production—may be used. Commonly reported galactagogues include
dietary or herbal supplements, for example, oats or fenugreek, and pharmaceutical treatments
such as domperidone [10]. Anecdotally, recent studies demonstrate widespread awareness and
use of there is increased promotion of dietary galactagogues such as lactation cookies [11, 12].
An examination of widely promoted recipes and commercially available products indicates
that lactation cookies contain highly variable combinations and quantities Internet searches
outline a variety of ingredients, including oats, brewer’s yeast and flaxseed.
A recent Cochrane review on the use of oral galactagogues for increasing breast milk pro-
duction in mothers of non-hospitalised term infants identified forty-one randomised clinical
trials [10]. The review found uncertain evidence that galactagogues improve breast milk vol-
ume or longer-term breastfeeding outcomes [10]. In contrast, several high-quality studies have
found domperidone effective in increasing breast milk production, specifically among mothers
of preterm infants [13, 14]. However, the use of domperidone remains controversial. Domper-
idone use at doses above 30 mg daily may present a risk of serious cardiac side effects [15].
However the relevance to breastfeeding women has been questioned as previous data on
increased cardiac risks mainly involved males and those aged over 60 years [16].
The considerable variation across studies concerning study population, intervention type,
and outcome evaluation has led to ongoing treatment uncertainties. This is reflected in the
recent guidelines issued by the Academy of Breastfeeding Medicine, which state that there is
insufficient evidence to recommend one galactagogue over another [17].
Despite conflicting evidence regarding the benefits of galactagogues in clinical practice,
there is evidence that breastfeeding women commonly use galactagogues, and use may be
increasing. For example, a 2012 Australian survey of 304 breastfeeding women observed that

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PLOS ONE Use of galactagogues while breastfeeeding

24% of respondents reported using a herbal galactagogue [18]. Estimates of uptake of the phar-
maceutical galactagogue domperidone appear more variable. Studies based on prescribing/dis-
pensing records from Australia, Canada and the UK show increasing trends in use, with
varying overall prevalence of use ranging from 2.7% to 20% [19–22]. In specific populations
such as following preterm birth, prevalence appears even higher, up to 30% [19, 21]. Further,
Grzeskowiak et al. examined queries relating to galactagogues at an Australian medicines
information centre from 2001 to 2014 that demonstrated a significant trend towards increased
phone calls regarding herbal galactagogues (0% to 23% of calls regarding galactagogues from
2001 to 2014) compared with a consistent interest in pharmaceutical galactagogues [23].
Unfortunately, the most recent studies evaluating galactagogue use only include data until
2015 and did not collect data on all types of galactagogues [12, 18–20]. Therefore, we sought to
undertake a survey to examine patterns of use of galactagogues, women’s experiences relating
to use, as well as their perceptions regarding effectiveness.

Methods
Ethics
This study was approved by the Human Research Ethics Committee at the University of Ade-
laide (approval number H-2019033934).

Survey administration
Women currently living in Australia and either currently breastfeeding or who had previously
breastfed were eligible to complete the survey. The survey was available online between 27 Sep-
tember 2019 and 12 December 2019. The survey consisted of part A, perceived safety and
knowledge of galactagogues, and part B, personal experiences and use of galactagogues, includ-
ing the self-perceived effectiveness, side effects and duration of use. If women had not taken
any galactagogues, they did not complete part B of the survey. This paper will focus predomi-
nantly on part B of the survey. Questions included in the survey covered the timing and dura-
tion of use of substances, sources of recommendation, side effects experienced and perceived
effectiveness. The perceived effectiveness of galactagogues was assessed using a 5-point Likert
scale from 1 (Not at all effective) to 5 (Extremely effective). The survey was tested for face
validity with two consumers and an academic breastfeeding expert. Only minor changes were
made to the survey before formal distribution through social networks (i.e. Facebook, Twitter,
email) of the Australian Breastfeeding Association [24, 25] (Australia’s national breastfeeding
support service, assisting more than 80,000 women each year, with over 1100 breastfeeding
counsellors available), Miracle Babies [26] (Australia’s leading organisation supporting prema-
ture and sick newborns, present in 143 Neonatal Intensive Care Units or Special Care Nurser-
ies in Australia), as well as research networks of the author’s respective institutions (e.g. The
Robinson Research Institute, and The University of Adelaide). Participants were encouraged
to share the survey and post links to the survey through their own social networks. The survey
was piloted with a small group of consumers (reviewed by representatives from the Australian
Breastfeeding Association and Miracle Babies) and academic experts in survey design, result-
ing in minor modifications before the final survey was launched. The complete survey is avail-
able as S1 File.
Study data were collected and managed using Research Electronic Data Capture (REDCap)
hosted at The University of Adelaide [27, 28]. REDCap is a secure, web-based software plat-
form designed to support data capture for research studies, providing 1) an intuitive interface
for validated data capture; 2) audit trails for tracking data manipulation and export proce-
dures; 3) automated export procedures for seamless data downloads to standard statistical

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PLOS ONE Use of galactagogues while breastfeeeding

packages, and 4) procedures for data integration and interoperability with external sources.
Only study investigators involved in the study had access to the data.
Completing the survey was voluntary, and no incentives were offered to participants.
Respondents had the opportunity to submit their responses anonymously or could choose to
include their contact details. When contact details were provided, respondents were
approached to participate in a separate qualitative study investigating women’s experiences of
using galactagogues. Only those who provided their contact details were able to withdraw their
responses, however none elected to withdraw their responses. A total of 2152 responses were
received, 7 responses were removed due to suspected duplicate entries based on identical
maternal characteristics provided in the entry section, and a further 90 were removed due to
births occurring outside of Australia.

Data analysis
Data were cleaned and analysed using STATA 14 (StataCorp LP, College Station, TX). Graphi-
cal images were produced using GraphPad Prism version 9 (GraphPad Software, La Jolla Cali-
fornia USA) and R Upset Package [29]. Maternal demographic characteristics and data on use
and experiences of galactagogues were described using descriptive statistics. The most com-
mon combinations of galactagogues used were graphed using an UpSet plot. Differences in
maternal characteristics according to any galactagogue use were compared using Student’s T-
test for means and Pearson’s Chi2 test for categorical variables. Duration of use was reported
separately for each galactagogue according to those that were continuing use at the time of the
survey and those that had stopped using it prior to completing the survey. Descriptive statistics
were used to report the means and standard deviations. Where data were non-normally dis-
tributed, the median and inter-quartile ranges were used. Statistical significance was defined as
a P < 0.05.

Results
A total of 1876 women responded to the survey. Maternal demographic characteristics of sur-
vey respondents are presented in Table 1. Briefly, the average age of women who responded
was 31.5 years old, while most had completed secondary schooling or higher (92%) and almost
half were primiparous (47%). At the time of the survey, 1217 (65%) of women reported they
were currently breastfeeding their infant. For women who reported currently breastfeeding,
the average infant age at the time of survey response was 10.7 months (mean ± 10 months stan-
dard deviation). Women who reported having ceased breastfeeding before completing the sur-
vey discontinued at an average of 21 months (mean ± 11 months standard deviation). Almost
half of all respondents (49%) felt they could not produce enough breast milk for their child,
and 63% sought help from a lactation consultant or breastfeeding expert. Of women who had
stopped breastfeeding prior to completing the survey (35%), 19% reported stopping due to low
milk supply.

Galactagogue use
Overall, 60% of women (n = 1120) reported taking one or more galactagogues during breast-
feeding. Women who had preterm births, saw a lactation consultant, were primiparous, had
perceived low milk supply, had a Caesarean section, or required supplemental feeding with
infant formula were more likely to use galactagogues (Table 1).
Information on individual galactagogue use is presented in Table 2. The most commonly
used galactagogue included lactation cookies (47%), brewer’s yeast (32%) and fenugreek
(22%). The use of ‘Other’ galactagogues were reported by 7.3% (n = 137) of women, which

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PLOS ONE Use of galactagogues while breastfeeeding

Table 1. Maternal characteristics according to any reported use of a galactagogue during breastfeeding.
Total survey population Did not use galactagogue Used a galactagogue P-value�
n (%) n (%) n (%)
N (Total = 1876) 2055 756 1120
Mothers age at delivery (years; mean ± SD) 31.5 ± 4.8 32 ± 5.2 31.2 ± 4.5 <0.001
Youngest child’s age at survey 0.005
0–< 6 months 560 (30) 223 (30) 335 (30)
� 6–< 12 months 370 (20) 124 (17) 246 (22)
� 12 months 936 (50) 405 (54) 527 (48)
State/Territory of youngest child’s birth 0.291
Australian Capital Territory 88 (5) 40 (5) 48 (4)
New South Wales 453 (24) 192 (26) 259 (23)
Northern Territory 23 (1) 9 (1) 14 (1)
Queensland 322 (17) 111 (15) 210 (19)
South Australia 378 (20) 150 (20) 225 (20)
Tasmania 43 (2) 17 (2) 25 (2)
Victoria 407 (22) 176 (24) 231 (21)
Western Australia 150 (8) 55 (7) 94 (9)
Completed secondary school 1887 (92) 698 (93) 1027 (92) 0.834
Primiparous 882 (47) 255 (34) 625 (56) < 0.001
Multiple birth 39 (2) 14 (2) 25 (2) 0.578
Preterm birth 218 (12) 66 (9) 150 (14) 0.002
Caesarean-section 621 (33) 192 (26) 426 (38) <0.001
Perceived low milk supply 928 (49) 162 (22) 761 (68) <0.001
Saw a lactation consultant 1184 (63) 381 (51) 798 (71) <0.001
Supplemented with infant formula 561 (30) 111 (15) 446 (40) <0.001
Any smoking during breastfeeding 66 (4) 23 (3) 43 (4) 0.358
�
Chi2 test between those that used and did not use a galactagogue.

https://doi.org/10.1371/journal.pone.0254049.t001

included oats (n = 87; 4.7%), malt products (n = 42; 2.2%), and flaxseed or linseed (n = 13;
0.7%).
With respect to domperidone and metoclopramide, which are only available by prescrip-
tion, these were most commonly prescribed by general practitioners (76% and 67% respec-
tively), followed by obstetricians/gynaecologists (20% and 10% respectively). For the
remaining galactagogues, the most common recommendation source was the internet (rang-
ing from 28–50%) and friends (ranging from 15–45%). Healthcare professionals such as com-
munity pharmacists (2–6%), general practitioners (2–7%), and obstetricians/gynaecologists
(1–2%) were uncommon sources of recommendation. One in three women taking herbal or
dietary galactagogues reported using two or more recommendation sources.
Among those reporting galactagogue use, 27% took only one substance, while 46% used three
or more galactagogues. The maximum number of galactagogues used was 10. The most common
patterns of galactagogue use are represented in Fig 1. Lactation cookies featured in the top five
different combinations of galactagogues used, and were the most used sole galactagogue.

Timing of commencement of galactagogues

Reported timing of commencement of galactagogue use is presented in Fig 2. Approximately
50% of galactagogues were commenced within the first four weeks postpartum, with 18.5%

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PLOS ONE Use of galactagogues while breastfeeeding

Table 2. Reported use of galactagogues and information sources from breastfeeding women (n = 1876).
Domperidone Metoclopramide Fenugreek Blessed Fennel Milk Ginger Brewer’s Lactation Combination of
Thistle Thistle yeast cookies herbs
Took substance (n 355 (19) 21 (1) 421 (22) 98 (5) 157 (8) 40 (2) 52 (3) 592 (32) 884 (47) 109 (6)
(%))
Mothers age at birth 31.8 ± 4.6 34.1 ± 4.2 31.7 ± 4.4 31.7 ± 4.3 31.5 ± 4.5 31.5 ± 4.5 31.2 ± 4.9 30.9 ±4.4 31 ± 4.4 32.1 ± 4.4
(years; mean ± SD)
Child’s age at survey�
0–6 months 110 (31) 2 (10) 105 (25) 29 (30) 44 (28) 13 (33) 19 (37) 158 (27) 264 (30) 42 (39)
6–12 months 79 (22) 4 (19) 86 (21) 18 (18) 43 (28) 8 (20) 16 (31) 135 (23) 210 (24) 23 (21)
12+ months 163 (46) 15 (71) 227 (54) 51 (52) 68 (44) 19 (48) 16 (31) 292 (50) 401 (46) 43 (40)
Maternal characteristics �
Primiparous 208 (59) 7 (33) 238 (57) 49 (50) 91 (58) 19 (48) 28 (54) 332 (56) 528 (60) 60 (55)
Preterm birth 74 (21) 7 (33) 70 (17) 17 (17) 22 (14) 9 (23) 7 (13) 85 (14) 125 (14) 14 (13)
Caesarean section 162 (46) 14 (67) 157 (37) 33 (34) 61 (39) 18 (45) 25 (48) 207 (35) 328 (37) 46 (42)
Perceived low milk 327 (92) 19 (90) 331 (79) 88 (90) 114 (73) 34 (85) 40 (77) 423 (71) 619 (70) 72 (66)
supply
Took only this 41 (12) 0 32 (8) 0 6 (4) 0 3 (6) 23 (4) 177 (20) 11 (10)
substance �
Two or more 57 (16) 1 (5) 168 (40) 34 (35) 43 (27) 15 (38) 14 (27) 272 (46) 421 (48) 27 (25)
recommendation
sources �
Who prescribed/recommended �
General Practitioner 271 (76) 14 (67) 30 (7) 5 (5) 3 (2) 1 (3) 3 (6) 22 (4) 21 (2) 2 (2)
Obstetrician/ 72 (20) 2 (10) 7 (2) 1 (1) 1 (1) 1 (2) 4 (1) 8 (1)
Gynaecologist
Midwife 41 (12) 2 (10) 67 (16) 14 (14) 8 (5) 3 (8) 3 (6) 65 (11) 87 (10) 6 (6)
Neonatologist/ 19 (5) 2 (10) 9 (2) 2 (2) 1 (0) 4 (0) 1 (1)
paediatrician
Internet search 119 (28) 30 (31) 54 (34) 20 (50) 17 (33) 278 (47) 356 (40) 34 (31)
Lactation consultant 90 (21) 26 (27) 18 (11) 6 (15) 3 (6) 76 (13) 117 (13) 9 (8)
Friends 87 (21) 15 (15) 28 (18) 11 (28) 12 (23) 211 (36) 395 (45) 26 (24)
Family 58 (14) 9 (9) 25 (16) 5 (13) 16 (31) 98 (17) 174 (20) 14 (13)
Child & family health 45 (11) 8 (8) 5 (3) 2 (5) 1 (2) 35 (6) 60 (7)
nurse
Naturopath 40 (10) 14 (14) 29 (18) 8 (20) 7 (13) 23 (4) 17 (2) 16 (15)
Neonatal nurse 36 (9) 5 (5) 7 (4) 4 (10) 3 (6) 30 (5) 54 (6) 1 (1)
Mother’s group 33 (8) 4 (4) 11 (7) 2 (5) 4 (8) 56 (9) 112 (13) 4 (4)
Social media 34 (8) 5 (5) 11 (7) 3 (8) 5 (10) 91 (15) 160 (18) 11 (10)
Blogs or online 24 (6) 4 (4) 6 (4) 1 (3) 5 (10) 56 (9) 77 (9) 4 (4)
discussion forums
Community 24 (6) 4 (4) 4 (3) 18 (3) 15 (2) 5 (5)
pharmacist
Breastfeeding helpline 10 (2) 2 (1) 1 (2) 12 (2) 20 (2) 2 (2)
Books 6 (1) 1 (1) 3 (2) 8 (1) 7 (1) 2 (2)
Podcasts 1 (0) 1 (2) 1 (0) 3 (0) 1 (1)
Other 15 (4) 2 (10) 18 (4) 7 (7) 14 (9) 3 (8) 1 (2) 21 (4) 44 (5) 14 (13)
�
(n (% of those who took each galactagogue)).

https://doi.org/10.1371/journal.pone.0254049.t002

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PLOS ONE Use of galactagogues while breastfeeeding

Fig 1. UpSet plot showing the use of different galactagogues and combinations thereof in breastfeeding women (n = 1120).
https://doi.org/10.1371/journal.pone.0254049.g001

commenced within the first seven days. Timing of commencement varied considerably
according to the individual type of galactagogue used. The proportion of women reporting
commencing individual galactagogues within the first seven days postpartum, ranged from 4
to 67%.

Effectiveness
The perceived effectiveness of galactagogues is reported in Fig 3. The mean perceived effective-
ness for eight of nine galactagogues was rated as being between ’slightly’ (2) and ’moderately’
(3) effective (Fig 3), except for domperidone which users reported as having the highest per-
ceived effectiveness (3.3 ± 1.2; mean ± standard deviation).

Side effects
Side effects women experienced according to galactagogue use are presented in Table 3. Dom-
peridone had the highest proportion of women reporting one or more side effects (45%), com-
pared to less than 20% of women using herbal galactagogues. For domperidone and
metoclopramide, 9% and 19% of women respectively stopped taking the medication due to
side effects. Greater than 20% of domperidone users experienced two or more side effects.

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PLOS ONE Use of galactagogues while breastfeeeding

Fig 2. Timing of commencement postpartum of galactagogues during breastfeeding.

https://doi.org/10.1371/journal.pone.0254049.g002

Duration of use
The median reported duration of use for each galactagogue is presented in Fig 4. Overall, the
median reported duration of use was longer in women who were currently taking a galactago-
gue at the time of the survey completion. Median durations of use varied from 2 (ginger) to 7
(combination of herbs) weeks for those who had stopped using a substance, and 6 (milk this-
tle) to 19 weeks (ginger) for those who were continuing use at the time of the survey.

Recommendations
The percentages of women who would recommend a particular galactagogue to a friend is pre-
sented in Fig 5. Overall, 75% would recommend a galactagogue to a friend. There appeared to
be a strong correlation between the perceived effectiveness of a galactagogue and whether or
not women would recommend it to a friend. Of the 25% of women who would not recom-
mend to a friend, 71% indicated a perceived lack of effectiveness as a reason.

Fig 3. Perceived effectiveness of galactagogues used by women who were breastfeeding (n = 1120).
https://doi.org/10.1371/journal.pone.0254049.g003

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PLOS ONE Use of galactagogues while breastfeeeding

Table 3. Self-reported side effects for galactagogues used by breastfeeding women (n = 1120).
Domperidone Metoclopramide Fenugreek Blessed Fennel Milk Ginger Brewer’s Lactation Combination of
thistle thistle yeast cookies herbs
Took substance (N) 355 21 421 98 157 40 52 592 884 109
Any side effects � 159 (45) 6 (29) 72 (17) 8 (8) 7 (4) 4 (10) 3 (6) 65 (11) 110 (12) 5 (5)
Two or more side 80 (23) 5 (24) 22 (5) 4 (4) 3 (2) 3 (8) 1 (2) 12 (2) 15 (2) 0 (0)
effects�
Individual side effects�
Weight gain 88 (25) 2 (10) 10 (2) 1 (1) 2 (5) 1 (2) 20 (3) 79 (9) 1 (1)
Headache 59 (17) 3 (14) 9 (2) 1 (1) 1 (3) 1 (2) 4 (1) 4 (0) 1 (1)
Dry mouth 47 (13) 3 (14) 11 (3) 2 (2) 1 (1) 2 (5) 1 (2) 9 (2) 11 (1) 1 (1)
Fatigue 31 (9) 3 (14) 4 (1) 2 (2) 6 (1)
Irritability 22 (6) 3 (14) 2 (0) 1 (3) 3 (1) 4 (0) 1 (1)
Depression 20 (6) 2 (10) 3 (1) 3 (1) 3 (0)
Stomach cramps 14 (4) 17 (4) 3 (3) 3 (2) 16 (3) 13 (1)
Nausea 13 (4) 3 (14) 11 (3) 3 (3) 4 (3) 1 (3) 1 (2) 11 (2) 4 (0)
Heart palpitations 13 (4) 3 (14) 3 (1) 2 (0) 2 (0)
/racing heart
Dizziness /fainting 12 (3) 5 (1) 1 (1) 1 (3) 4 (1) 5 (1)
Involuntary 4 (1) 2 (10)
movements /jerking
Skin rash 2 (1) 2 (0) 1 (0) 1 (0)
Other 12 (3) 14 (3) 1 (1) 2 (1) 7 (1) 12 (1) 1 (1)
Body odour 11 (3)
Decreased supply 6 (1)
Gas/bloating 8 (1)
�
n (% of those who took each galactagogue).

https://doi.org/10.1371/journal.pone.0254049.t003

Discussion
In this large contemporary survey of Australian women, galactagogue use was reported by
60% of women at some stage during their lactation. Women commonly reported using multi-
ple galactagogues, with median durations of use from 2–19 weeks or more and 50% of galacta-
gogues being commenced within the first four weeks postpartum. Galactagogues appeared to
be well tolerated, except for pharmaceutical galactagogues, where side effects were reported by
approximately 50% of women. The widespread utilisation and experiences of galactagogues in
postpartum women highlights the importance of future research aimed at (a) understanding
why women are using them in the face of limited evidence and guidance about their use, and
(b) improving evidence regarding the efficacy and safety of individual galactagogues to support
informed decision making.
The need to develop additional strategies to support breastfeeding mothers is reflected in
nearly half of our sample reporting that they felt they could not produce enough milk for their
child at some stage, with almost 1 in 5 women discontinuing breastfeeding due to concerns
about their milk supply. It is uncertain whether concerns related to breast milk supply were
real or perceived, determining which has been often recognised as a common challenge within
clinical practice settings [6]. The high proportion of women reporting concerns about their
breast milk production in our study (approximately 50%) is consistent with previous studies
from Australia (45%) and the United States (76%) [12, 30].

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PLOS ONE Use of galactagogues while breastfeeeding

Fig 4. Duration of galactagogue use by women who had (a) stopped use and those who are (b) continuing use at the time of survey completion
(median, inter-quartile range, and 5th to 95th percentile whiskers).
https://doi.org/10.1371/journal.pone.0254049.g004

Our data showed that women were more likely to take a galactagogue based on several preg-
nancy/birth characteristics such as primiparity, preterm birth or caesarean delivery, as well as
perceived low breast milk supply. These risk factors are consistent with those previously
reported in the literature, and commonly associated with breastfeeding difficulties [8, 22, 31].

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PLOS ONE Use of galactagogues while breastfeeeding

Fig 5. Women’s recommendations of galactagogues to a friend and their reasons for not recommending.
https://doi.org/10.1371/journal.pone.0254049.g005

A previous 2012 survey of women in Western Australia found that 24% of 304 respondents
reported using a herbal galactagogue during breastfeeding [18]. The most common galactago-
gues included fenugreek (18%), blessed thistle (6%) and fennel (5%) [18]. In comparison, a
2015 US survey of 188 women reported herbal galactagogue use in 46% of respondents [12].
The most common galactagogues were fenugreek (46%), fennel (16%) and milk thistle (13%)
[12]. However, the survey was restricted to women who reported using or intending to use
galactagogues. Notably, neither of these studies collected data regarding the use of the dietary
galactagogues lactation cookies or brewer’s yeast which were the most commonly reported
galactagogues in our survey. Regarding the use of herbal galactagogues, we observed similar
high usage of fenugreek, and lower but notable use of fennel [12]. The number of women
reporting using domperidone in our survey (1 in 5 respondents) was higher than initially
anticipated. A previous Australian audit of domperidone use in the postpartum period at a sin-
gle tertiary maternity teaching hospital from 2000 to 2010 reported a prevalence of 5% [19].
However, as the audit was restricted to domperidone supplied from the hospital pharmacy
department, it likely represents an underestimation of total use [19]. By comparison, interna-
tional studies evaluating domperidone use from 2011 to 2015 have produced widely varying
prevalence ranging from 2% in the UK [20] 2.7% in the US [12], and 20% in Canada [21].
Among high-risk subgroups, such as women with preterm birth, the prevalence of domperi-
done use increased to 30% [19, 21]. Such differences may reflect differences in inter-country
domperidone availability, clinical practice guidelines and prescriber/consumer awareness.
Domperidone had the highest perceived effectiveness rating but also had the highest pro-
portion of women reporting side effects. While previous meta-analyses provide moderate-
quality evidence to support the use of domperidone in managing lactation insufficiency fol-
lowing preterm birth [13], there is no such equivalent evidence that it is effective in mothers of
otherwise healthy term infants [10]. This represents a significant evidence-gap given wide-
spread uptake of domperidone use following term birth.
While fenugreek was the most commonly used herbal galactagogue and appeared to be
well-tolerated, a recent meta-analysis demonstrated that it seems to be no more effective than
a placebo in treating lactation insufficiency [10, 32].

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PLOS ONE Use of galactagogues while breastfeeeding

The observation that a high proportion of women are taking galactagogues based on recom-
mendations from the internet is consistent with a 2015 survey conducted in the United States
demonstrated that 48% of women taking fenugreek sourced their information online. The
same study also found that up to 85% of women sought information from sources other than
their primary care provider or lactation consultants [12]. Frequent use of information sources
other than healthcare professionals raises concerns regarding whether or not women are being
provided with evidence-based information regarding the use of galactagogues to support
informed decision making. This is backed up by findings from an Australian survey of wom-
en’s attitudes to herbal medicine during lactation that found that while the internet was again
a common source of information, women often doubted the reliability of information from
the internet and cited the need for information and resources endorsed by reputable breast-
feeding organisations and healthcare professionals [30, 33]. The second highest source of
information was women’s friends, which may suggest that women prioritise others’ anecdotal
experiences over that of evidence-based resources or trained health care professionals.
The fact that 1 in 6 respondents started using various galactagogues within the first seven
days postpartum raises potential concerns, particularly given the challenge of assessing the
adequacy of breast milk production in the early postpartum period [34, 35]. These findings
may indicate that women may be turning to galactagogues prophylactically (without actually
having low breast milk supply) or using them as early treatments before trying non-pharmaco-
logical strategies. While 71% of women reported seeing a lactation consultant, we do not know
when this occurred relative to the commencement of galactagogues. The observation that 20%
of galactagogue use occurred after three months postpartum highlights the importance of con-
tinued breastfeeding support beyond the immediate postpartum period.

Strengths and limitations

This survey is the first to examine galactagogue use, the timing and duration of use, as well as
perceived effectiveness and side effects of common galactagogues in the community. This
study has several limitations. Our survey used non-probabilistic sampling and snowballing
sampling techniques, making it difficult to extrapolate findings to the broader Australian pop-
ulation of breastfeeding women. Based on national Australian perinatal statistics, while our
survey included a higher proportion of women born in Australia (86% vs 65%), the distribu-
tion of other key demographic and birth characteristics known to influence breastfeeding out-
comes such as maternal age at delivery (31.5 years vs. 30.4 years), delivery by caesarean section
(33% vs. 35%), preterm birth (12% vs. 9%), and prevalence of overweight/obese (49% vs 45%),
were similar [36].
The survey measured women’s perceived effectiveness and did not utilise objective mea-
sures of changes in breast milk supply. The support and clinical care women received during
breastfeeding were also not reported, meaning some women’s perceived increase in supply
may have been unrelated to galactagogue use.
Lactation cookies were provided as one of ten listed galactagogues that women could
choose from. However participants were not provided with a definition of lactation cookies
nor a pre-defined list of ingredients. As such, our survey did not account for possible varia-
tions in ingredients between different lactation cookies, and there is likely to be some crossover
with other galactagogues listed in the survey, particularly brewer’s yeast which is one of the
most common ingredients in lactation cookies. While 1217 women were breastfeeding at the
time of the survey, responses were obtained from 657 women who had completed breastfeed-
ing up to an average of 3.9 years before completing the survey. This raises the possibility of
errors related to women’s ability to recall exact timings and durations of use correctly.

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PLOS ONE Use of galactagogues while breastfeeeding

However, previous studies suggest the degree of error is likely to be small, with a 1-month
error in reporting among women recalling information from 1 to 3.5 years prior [37]. Further-
more, for women continuing to breastfeed and taking a galactagogue at the time of completing
the survey, it is not possible to correctly define the total duration of use or their complete set of
experiences. Lastly, we did not ask about galactagogue use before birth. Some women use
herbal galactagogues before birth to stimulate lactation initiation, which is of concern as some
popular herbal galactagogues such as fenugreek and milk thistle may cause uterine contrac-
tions [38].

Concluding remarks
This large online survey demonstrates that the use of galactagogues appears to be very com-
mon in Australia. Women seem to be using multiple galactagogues during breastfeeding, with
evidence of frequent initiation in the first week postpartum and long durations of use. The
incidence of side effects appeared higher for women taking pharmaceutical agents compared
to herbal galactagogues. However, a number of side effects were still reported by women using
herbal or food-based galactagogues, suggesting they are not completely benign. The high prev-
alence of women taking galactagogues based on recommendations obtained through the inter-
net or friends, rather than healthcare providers, raises concerns surrounding the potential
quality of the information they receive, particularly in light of the lack of evidence surrounding
the effectiveness and safety of most galactagogues. Overall, our findings highlight the need for
further high-quality research, particularly appropriately powered randomized controlled trials,
to generate robust evidence about the efficacy and safety of galactagogues to support evidence-
based strategies to improve breastfeeding outcomes.

Supporting information
S1 File. Boosting breast milk supply survey. All survey questions asked regarding women’s
use and experiences with substances to boost breast milk supply.
(PDF)

Author Contributions
Conceptualization: Gabriella Zizzo, Alice R. Rumbold, Lisa H. Amir, Luke E. Grzeskowiak.
Formal analysis: Grace M. McBride, Luke E. Grzeskowiak.
Funding acquisition: Gabriella Zizzo, Alice R. Rumbold, Lisa H. Amir, Luke E. Grzeskowiak.
Investigation: Grace M. McBride, Robyn Stevenson, Gabriella Zizzo, Alice R. Rumbold, Lisa
H. Amir, Luke E. Grzeskowiak.
Visualization: Grace M. McBride, Luke E. Grzeskowiak.
Writing – original draft: Grace M. McBride.
Writing – review & editing: Grace M. McBride, Robyn Stevenson, Gabriella Zizzo, Alice R.
Rumbold, Lisa H. Amir, Amy K. Keir, Luke E. Grzeskowiak.

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Iranian Journal of Pharmaceutical Research (2011), 10 (1): 167-172 Copyright © 2011 by School of Pharmacy
Received: July 2009 Shaheed Beheshti University of Medical Sciences and Health Services
Accepted: December 2009

Original Article

A Double-Blind Randomized Clinical Trial for Evaluation of

Galactogogue Activity of Asparagus racemosus Willd.

Mradu Guptaa*and Badri Shawb

Department of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research,

a

294/3/1, A.P.C. Road, Kolkata 700009. bDepartment of Kayachikitsa, Institute of Post Graduate
Ayurvedic Education and Research, 294/3/1, A.P.C. Road, Kolkata 700009 , India.

Abstract

Asparagus racemosus Willd. has repeatedly been mentioned as a galactogogue in Ayurvedic

literature and has been confirmed through animal experiments as well. This randomized double-
blind clinical trial evaluates its galactogogue effect in 60 lactating mothers by measurement
of changes in their prolactin hormone level during the study. Several secondary parameters
namely mothers’ weight, babies’ weight, subjective satisfaction of mothers and well-being and
happiness of babies were studied to corroborate the primary findings. The oral administration
of the research drug led to more than three-fold increase in the prolactin hormone level of the
subjects in the research group as compared to the control group. The primary findings were
corroborated by the secondary outcome measures and were found to be statistically significant
(p < 0.05).

Keywords: Asparagus racemosus; Galactogogue; Clinical trial; Ayurvedic medicine.

Introduction The chemical analysis of the roots of A.

racemosus Willd. with different solvents has
Asparagus racemosus Willd. (Liliaceae revealed the absence of flavonoids and the
family) is a tall, climbing, thorny undershrub presence of several pharmacologically active
with triquetrous spiny branches and white flowers saponins such as shatavarins I-V (antioxytocic,
which is found in tropical and sub-tropical immunomodulator), sarasasapogenin,
regions of india, australia and africa. It contains steroidal saponins (antioxytocic), immunoside
a large number of fleshy tuberous fasciculate (immunomodulator), anthocynanin
roots which are soft, pliable and light pale to (immunomodulator, antioxidant, blood
brown in color (1, 2). It has been prominently cholesterol reducer), cyanidin glycosides (anti-
mentioned in Ayurvedic literature due the protozoal), phytoecdysteroids (antimicrobial),
diuretic, antidysenteric, nutritive, galactogogue, glycoside-AR-4 (anti-protozoal), asparagamine
aphrodisiac and antispasmodic properties of its A (antioxytocic, antitumor), racemofuran
roots (3). Its role as a milk enhancing substance (antioxidant) and diosgenin (hepato-protector,
or galactogogue, has been mentioned in several antitumor) (6-8).
ancient Ayurvedic text books such as Charak Mother’s milk is the most suitable nutrient for
samhita and Susruta samhita (4, 5). the baby. During the first six months of life, the
breast milk is the optimal source of nutrition for
* Corresponding author: babies. It is comprised of nutrient proteins, non-
E-mail: [email protected] protein nitrogen compounds, enzymes, lipids,
Gupta M and Shaw B / IJPR (2011), 10 (1): 167-172

oligosaccharides, hormones, growth factors, survey of india, shibpur, howrah. A voucher

host defense agents, vitamins A, C, B complex, specimen (No. BM/UCM/007) was deposited in
binding proteins, lysozyme and antibodies, as the herbarium before their utilization. The roots
well as many other factors that build a strong and were cleaned, dried in shade and fine-powdered
healthy human being. The immunoprotective up to 80 mesh size. The root powder was put
elements of breast milk include secretory into capsules depending on the bodyweight of
IgA, lactoferrin, lysozyme, oligosaccharides, each subject and labeled “R”. Similarly placebo
milk lipids and milk leukocytes. However, the capsules were prepared with fine rice powder
secretion of milk from the mammary glands is and labeled “C”.
controlled to a great extent by the concentration
of prolactin hormone, a high molecular weight Acute oral toxicity
protein hormone secreted by the anterior pituitary Acute oral toxicity refers to the adverse
gland, in the mother’s blood vessels. There is effects that occur following oral administration
enough evidence now to support the belief that of a single dose of a substance or multiple doses
the prolactin hormone is directly responsible for given within 24 h. OECD Guideline No. 425
promotion of milk secretion and that abnormally (acute oral toxicity-acute toxic class method)
low levels of this hormone is indicative of was undertaken as a test procedure to ascertain
deficient lactation in mothers (9). the acute oral toxicity. In addition to the
Oral administration of roots of Asparagus estimation of LD50 and confidence intervals, the
racemosus Willd. increased the milk yield in test allows observing the signs of toxicity. Six
rats, cows, buffaloes (10-13) and goats (14), The groups each containing six swiss albino mice
crude alcoholic extract of the roots increased the weighing 25-30 g maintained in standardized
weight of mammary glands in post-partum and environmental conditions (animal house Reg.
oestrogen-primed rats and the uterine weight No. 1180/ac/08/CPCSEA) were fasted 12 h
in oestrogen-primed group (11). However, there before the experiment and administered the
were no scientific evaluations based on clinical drug sample orally in the dose of 300 mg/Kg,
trials on lactating mothers about the galactogogue 500 mg/Kg, 1000 mg/Kg, 2000 mg/Kg and 5000
effect of this medicinal plant. mg/Kg in 1 mL of aqueous solvent. The physical
This research was aimed at the clinical activity, behavior and mortality of each mice of
evaluation for galactogogue efficacy of each group is observed and recorded after 1/2 h,
Asparagus racemosus Willd. roots by direct 2 h, 4 h, 8 h, 12 h, 24 h and 48 h.
measurement of the prolactin hormone level and
assessment of the secondary outcome measures. Subjects
All the subjects were lactating mothers who
Experimental were selected after general examination from
the medical outdoor patients department of the
This clinical trial was a double-blind, Institute of Post Graduate Ayurvedic Education
randomized, placebo-controlled, parallel-group and Research at the S. V. S. P. Hospital, Kolkata
study involving a total of 60 subjects. The study using the following inclusion criteria: (I) age of
was carried out at the medical outdoor patients mother between 20-40 years; (II) age of infant
clinic department of the Institute of Post Graduate up to 6 months; (III) having one or more of the
Ayurvedic Education and Research at the S. V. S. following symptoms: deficient lactation, infant’s
P. Hospital, Kolkata. crying just after feeding, painful sensation in
breasts during the time of feeding, loss of appetite
Preparation of the research drug and its in mother or the manifestation of any anxiety
administration disorder which could effect the lactation.
Fresh roots of Asparagus racemosus Willd.
were collected from a reputed herb supplier of Ethical aspects
kolkata. These were authenticated and identified All subjects were given verbal and written
by the department of ethnobotany, botanical information about the potential risks and benefits

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of participation in the study. Written consent was hormone level before and after the treatment.
required before randomization. The research To that end, a 2 mL sample of blood was drawn
followed the guidelines of the declaration of from each subject to ascertain the initial and
helsinki and tokyo for humans. The institutional final level of prolactin hormone level during the
clinical research committee of the participating clinical study. The quantitative determination
center approved the study protocol. of prolactin hormone concentration (ng/mL)
in human serum of blood sample was done
Treatment allocation and blinding by Micro plate Immunoenzymometric Assay
Initially 70 subjects were selected for the (ELISA) technique at ashoka laboratory, kolkata
purpose of this study, out of which 60 were finally using the kit of monobind. Inc.
followed up. These subjects were randomly The secondary outcomes measured during
allocated to one of the two equal-sized treatment this study were the changes in mothers’ weight,
groups and received the treatment dose of 60 babies’ weight, subjective satisfaction of mother
mg Kg-1 body weight per day. The treatment regarding the state of lactation and the well-
groups included group R (research group) which being and happiness of babies. The mothers’
received the root powder of research drug (60 mg weight and babies’ weight were recorded just
Kg-1 body weight per day) and group C (control before and after the period of clinical trial. The
group) who were administered rice powder subjective satisfaction of mothers regarding
as placebo (60 mg Kg-1 body weight per day). the state of lactation and the well-being and
The treatment consisted of oral ingestion of the happiness of babies were rated on a graded scale
treatment drug in the form of capsules three times ranging from 1 to 5 (1 denoting unsatisfactory
daily with milk for 30 days. All the subjects were and 5 representing highly satisfactory).
advised to immediately discontinue the use of
the drug in case of any serious side effects. Statistical analysis
The study medication was provided in white The results were analyzed statistically using
paper boxes, numbered consecutively with a the student’s t-test. The values of p < 0.05 were
medication number. The treatment allocation considered statistically significant, p < 0.01 were
schedule was based on computer-generated considered very significant and the values of
random numbers. The treatment codes resided p < 0.001 were taken as highly significant.
with the principal investigator and the local
investigators were not aware of treatment Results and Discussion
assignments. No treatment code was broken
before the last follow-up visit completion. General information
All the subjects were advised to lead their A total of 60 subjects were randomized
normal lives with their family during the study and received trial medication after providing
period subject to the following conditions: the written agreement of their participation in
(I) no use of any contraceptive pills or steroid the trial. The mothers were of an average age
containing drugs which could affect the normal of 25.6 years while the average age of infants
hormonal balance, (II) normal feeding technique was 2.8 months. 79% of the patients belonged
and schedule for infants, (III) making sure of to the minority muslim community, while 71%
the babies’ burping after the feeding and (IV) resided in an urban or semi-urban area. There
avoiding any situation or events which could was no significant group difference with regard
cause abnormal anxiety or tension. Follow-up to distribution of age, community or habitat. A
visits were done on a weekly basis to undertake total of 10 patients, who did not participate in the
the physical examination of mother and child entire trial or did not turn up for regular follow-
and for analysis of their symptoms. up visits, were excluded from the study.

Outcome measures Acute oral toxicity

The primary outcome measure in this study No signs of oral toxicity were observed
was the biochemical estimation of prolactin during the short-term analysis in mice but

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Gupta M and Shaw B / IJPR (2011), 10 (1): 167-172

Table 1. Mean percent increase in primary and secondary parameters during clinical trial.
Mean percent increase
Parameter
Group R Group C
Primary outcome:
Mean prolactin hormone level 32.87 ± 6.48 a 9.56 ± 4.57 a
Secondary outcomes:
Mean weight of mother 3.78 ± 0.68 a 1.37 ± 0.44 a
Mean weight of babies 16.13 ± 3.65 a 5.68 ± 2.57 a
Subjective satisfaction of mother 1.54 ± 0.28 a 0.48 ± 0.33 a
Overall well-being & happiness of babies 1.27 ± 0.45 a
0.29 ± 0.23 a
n = 20 a: p < 0.05 b: p < 0.01 c: p < 0.001
The obtained results proved to be statistically significant (p < 0.05) using the 2-tailed t-test.

mortality was noticed in long-term study at the group as given in Table 1.

dose of 5000 mg/Kg. The results obtained for the secondary
outcome measures were found to be statistically
Evaluation of increase in prolactin hormone significant (p < 0.05).
level Nature has intended to strengthen the bond
The mean prolactin hormone level of the between the mother and her infant by making
subjects showed a percentage increase of mother’s milk a necessity for the baby. It has
32.87 ± 6.48 through the study period in case of been proved that the breast milk is the best milk
the research group (group R) while the control for the new born babies (15). The digestive
group (group C) showed a percentage increase of system in a newborn baby is so delicate that
only 9.56 ± 4.57 in the mean prolactin hormone it can easily digest only the breast milk. It is
level during the same period as detailed in not only nutritious for the baby, but also helps
Table 1. protect him/her from almost all the infections
by boosting his/her immunity level. The World
Evaluation of secondary outcome measures Health Organization (WHO) and the American
During the study period, the weight of the Academy of Pediatrics (AAP), both recommend
mothers showed a mean percentage increase of exclusive breastfeeding for the first six months
3.78 ± 0.68 in case of group R, while the mean of life and then supplemented breastfeeding for
percentage increase was 1.37 ± 0.44 in case at least one year and up to two years or more
of group C. Similarly, the average percentage (16, 17). Exclusive breastfeeding for the first six
increase in the weight of babies was 16.13 ± 3.65 months of life provides continuing protection
in case of group R and 5.68 ± 2.57 in case of against diarrhea and respiratory tract infections
group C during the treatment period. that are more common in babies formula-fed (18).
The first secondary parameter, namely the The prolactin hormone produced in the anterior
subjective satisfaction of mothers regarding the pituitary gland, promotes milk secretion in the
state of lactation, showed an average increase mother. Higher levels of prolactin hormone in
of 1.54 ± 0.28 rating points in case of group R the lactating mother lead to promotion of milk
and 0.48 ± 0.33 rating points in case of group secretion (6, 19).
C during this period. The overall well being According to the Ayurvedic medicine,
and happiness of babies, the other secondary mother’s milk is the best nutritive substance for
outcome measure, was also rated by the mothers the child since it is sweet, emollient, laxative,
just before and after the study period. This wholesome, appetizing and easy to digest. It
parameter showed a mean increase of 1.27 ± contains all the necessary vitamins and minerals
0.45 points in case of the research group and which protect and nurture the baby. It originates
0.29 ± 0.23 rating points in case of the control from the breasts when the essence of digested

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 A Double-Blind Randomized Clinical Trial for Evaluation of ...

food circulates all over the body and gets the control group. The research drug was also
concentrated in the breasts of mother (4, 5). found to be quite safe from the viewpoint of
Deficient lactation can be caused by a number acute oral toxicity. The statistical analysis of the
of factors such as anger, grief, lack of affection results showed that the findings were statistically
towards the child and etc. Asparagus racemosus significant (p < 0.05).
Willd., has been described in many ancient
Ayurvedic textbooks regarding its galactogogue Conclusions
action. The administration of alcoholic extract
of its rhizome in adult pregnant female albino Evaluation of the galactogogue action
rats suggests an estrogenic effect of Shatavari of the roots of Asparagus racemosus Willd.
on the female’s mammary gland and genital during clinical trial on lactating mothers
organs (20). The extract of Shatavari has been having symptoms of deficient lactation
shown to increase both the weight of mammary exhibits significant galactogogue activity in
lobulo-alveolar tissue and the milk yield in comparison with the control group without any
animal experiments. This effect was attributed significant acute toxicity effect. A probable
to the action of released corticosteroids or reason for this galactogogue effect could be
an increase in prolactin. Shatavarins I-V, the the presence of steroidal saponins in this plant.
steroidal saponins, may be responsible for the This drug has been scientifically validated for
hormonal like effect of Shatavari and explain its galactogogue activity by using the modern
its traditional use as a reproductive tonic (21, parameters such as the prolactin hormone which
22). The presence of steroidal saponins and is biochemically responsible for the lactation
sapogenins constituents has been shown to and also other associated symptoms. The overall
directly contribute in the lactogenic effect of research findings corroborate and validate the
Asparagus racemosus (23, 24). Its galactogogue galactogogue activity of the research drug, which
activity was evaluated experimentally on rats, has been traditionally ascribed to it in the ancient
cows, buffaloes and goats, but there were no text Charak Samhita.
similar findings regarding its galactogogue
effects on human subjects (10-13). References
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