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CTRI Number  CTRI/2024/03/063574 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy and Safety of Shatavari granules to increase milk in women after delivery. 
Scientific Title of Study   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 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
Galactagogue-1089-2024-01 Version 1; dt. 12th February 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashvini Deshmukh 
Designation  Principle investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Department of Obstetrics and Gynecology,1st floor, OPD NO.67 D Y Patil Medical College and Hospital, Nerul, Navi Mumbai 400706, Maharashtra

Mumbai
MAHARASHTRA
400706
India 
Phone  09970123758  
Fax    
Email  deshmukhashvini8@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashvini Deshmukh 
Designation  Principle investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Department of Obstetrics and Gynecology,1st floor, OPD NO.67 D Y Patil Medical College and Hospital, Nerul, Navi Mumbai 400706, Maharashtra

Mumbai
MAHARASHTRA
400706
India 
Phone  09970123758  
Fax    
Email  deshmukhashvini8@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashvini Deshmukh 
Designation  Principle investigator 
Affiliation  D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai 
Address  Department of Obstetrics and Gynecology,1st floor, OPD NO.67 D Y Patil Medical College and Hospital, Nerul, Navi Mumbai 400706, Maharashtra

Mumbai
MAHARASHTRA
400706
India 
Phone  09970123758  
Fax    
Email  deshmukhashvini8@yahoo.com  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Dr Ashvini Deshmukh 
Address  DY Patil Medical College and Hospital, Nerul, Navi Mumbai 400706, Maharashtra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashvini Deshmukh  D.Y Patil University School of Medicine  Department of Obstetrics and Gynecology,1st floor, OPD NO.67 D Y Patil Medical College and Hospital, Nerul, Navi Mumbai 400706, Maharashtra
Mumbai
MAHARASHTRA 		 9970123758

deshmukhashvini8@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee D Y Patil Medical College Nerul Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post-partum Women 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Galact granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 16 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Placebo(2) Medicine Name: Whey Protein, Reference: NA, Route: Oral, Dosage Form: Granules, Dose: 100(mg), Frequency: bd, Twice a day, Duration: 16 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  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 Galat 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, 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Total volume (ml) of breast milk produced on the third post-partum day; Measurement by Breast pump (Manual/Automatic).
2.Mean time noticeable from birth to evident breast fullness after delivery.  		 Day 3 (72 hours) 
 
Secondary Outcome  
Outcome  TimePoints 
Total volume (ml) of breast milk produced after breast fullness; measurement by breast pump (Manual/Automatic)  Week 4, Week 16 
Mean change in protein content (albumin and globulin) and specific gravity in breast milk during post-partum women after delivery.  Baseline, Week 4, Week 16 
Mean change in serum prolactin levels in post-partum women after delivery.   Baseline, Week 4, Week 16 
Mean time (hours) to evident noticeable breast fullness after last breast feeding (measured during daytime).   Week 4, Week 16 
Use of infant formula feed.   Week 4, Week 16 
Self‐reported insufficient milk (SRIM) assessment by mother for their decision to wean their infant.  Week 4, Week 16 
Proportion of infants developing infections.   Week 4, Week 16 
Mean change in infant weight after delivery.  Day 3 (72 hours), Week 4, Week 16 
Proportion of women experiencing Treatment-Emergent Adverse Events (TEAEs).   Baseline, Week 4, Week 16 
Proportion of women experiencing Treatment-Emergent Serious Adverse Events (TESAEs).  Baseline, Week 4, Week 16 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

  1. All eligible women who meet the inclusion and exclusion criteria will be part of the study.

    Participants will be informed about the purpose of the study and signed informed consent will be taken.

    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.

    The adverse events, either spontaneously reported by the participant, or noticed by the clinician will be recorded during the study.


 
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