| CTRI Number |
CTRI/2025/10/095688 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The role of an Ayurvedic medicated milk formulation in supporting maternal milk supply and infant growth: A research study. |
|
Scientific Title of Study
|
Impact of Sthira kshirpaak on lactogenesis II of nursing Mothers and on weight velocity of their neonates A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithila Amin Shreeniwas |
| Designation |
Associate Professor |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
B3-603 Shree Saraswati CHSL,
NG Acharya Marg, Chembur, Mumbai.
Dr. D. Y. Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
Mumbai
MAHARASHTRA
400071
India |
| Phone |
09969947997 |
| Fax |
022-27709994 |
| Email |
mithila.amin@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Professor |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
Dr. D. Y. Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9321835616 |
| Fax |
022-27709994 |
| Email |
kalpana.dhuri@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithila Amin Shreeniwas |
| Designation |
Associate Professor |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
B3-603 Shree Saraswati CHSL,
NG Acharya Marg, Chembur, Mumbai.
Dr. D. Y. Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
MAHARASHTRA
400071
India |
| Phone |
09969947997 |
| Fax |
022-27709994 |
| Email |
mithila.amin@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DY Patil Ayurved Hospital Sector7 Nerul Navi Mumbai 400706 |
| DY Patil Medical Hospital Sector5 Nerul Navi Mumbai 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Mithila Amin Shreeniwas |
| Address |
DY Patil School Of Ayurved
Sector 7 Vidyanagar Nerul
400706 |
| Type of Sponsor |
Other [Individual Sponsor (Self)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mithila Amin Shreeniwas |
DY Patil Ayurved Hospital |
DY Patil Sector 7
Vidyanagar Nerul
400706
Mumbai
MAHARASHTRA |
09969947997
mithila.amin@dypatil.edu |
| Dr Mithila Amin Shreeniwas |
DY Patil Medical Hospital |
Sector 5 Nerul, Navi Mumbai, 400706.
Mumbai
MAHARASHTRA |
09969947997
mithila.amin@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| RAPMCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O923||Agalactia. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sharkara (Cane Brown Sugar)), Reference: charak samhita sutrasthana 27:240, Route: Oral, Dosage Form: Ksheerpaka, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Sita), Additional Information: -Placebo | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sthira, Reference: Asthtang Hruday Uttarstahana 1:20, Route: Oral, Dosage Form: Ksheerpaka, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Sita), Additional Information: -Trial Drug |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
For mothers:
Registered Primi gravida mothers who have taken ANC.
In Reproductive age group of 15-49years.
Clinically Stable
For Neonates:
Live Singleton babies of either sex
With birth weight appropriate for Gestational age
Clinically Stable
|
|
| ExclusionCriteria |
| Details |
For mothers:
Contra-indicated to breast feed
Those under medications that affect the study results
Those with co-existing medical conditions that adversely affect lactation
Those with major anatomical breast anomalies
Critically ill
For neonates
Those with birth weights less than 2500grams or more than 3500 grams
those with Gestational Age less than 37 weeks or greater than 42 weeks
those with medical conditions which necessitate weaning or total parental nutrition
Those with major congenital anomalies
Critically ill neonates |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lactogenesis II time
Latch Score in hours |
Postpartum Day 1 to day 5 daily assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neonatal weight loss or gain in grams |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - via Publications
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title Impact of Sthira Kshirapaak on lactogenesis II in nursing mothers and on weight velocity of their neonates. A randomized controlled trial.
Introduction Lactogenesis II is referred to as milk coming in which represents the onset of copious milk secretion, breast fullness and increased volume.
Need of the Study Delayed Lactogenesis II with a global incidence of 17 to 44 percent has significant clinical implications on weight and growth outcomes of neonates.
Objectives Primary To assess the effect of Sthira on the duration of Lactogenesis II. Secondary To assess the impact of Sthira Kshirapaak administered to mothers on the weight velocity of neonates.
Materials and methods Setting Multi centric trial
Procedure The dyad of mothers and neonates born in the maternity ward of the study centers screened for inclusion and exclusion criteria and willing to give an informed consent to participate in the trial will be registered. PIS will be given to the participants and written informed consent/ assent will be taken and they will be randomized into 2 groups.
Assessment Baseline data and periodic assessments will be done at the specified intervals. ie. Daily from day 1 of Post-partum until day 5 postpartum.
Objective Parameters Expressed milk volume Latch Score Neonatal weight gain or loss per day Test Weight
Subjective parameters in mothers based on Maternal perception of breast feeding in neonates based on Satiety urine frequency stool frequency etc.
Intervention The Trial group will receive Sthira and Sita 6 grams each to be processed with milk while the Control group will receive Brown Cane Sugar and Sita 6 grams each also to be processed with milk. Both the intervention as well as placebo will have identical packing.
Duration of medication 5 days
Duration of the study 7 days
Ethical considerations The study will commence after obtaining permission from the institutional ethical committee and after CTRI approval, following the GCP guidelines.
Statistical Analysis Will be done using appropriate software.
References Reference management systems will be used.
Conflicts of interest Conflicts of interest if any shall be declared. |