| CTRI Number |
CTRI/2025/02/080963 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Survey Study on the breast milk of lactating mothers of Vadodara City Gujarat |
|
Scientific Title of Study
|
A Cross sectoional study on Stanyadushti (breast milk pH and foam test) in lactating mothers of Urban Vadodara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kairav MDAyuPaediatric Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of ayurveda |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
08128281198 |
| Fax |
|
| Email |
Kairavpatel21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul University Limda Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Kairav Patel |
| Address |
Parul Institute of Ayurved Parul University At post Limda Waghodia Vadodara Gujarat India 391760 |
| Type of Sponsor |
Other [Self - PG scholar] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Parul University |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kairav Patel |
Parul Institute of Ayurved |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University
Vadodara
GUJARAT |
08128281198
Kairavpatel21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionsl Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Lactating mothers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Mothers having infants in the age group of 1–6 months irrespective of the health condition of the infants |
|
| ExclusionCriteria |
| Details |
Mothers suffering from chronic systemic diseases (HIV, TB, etc.) and postnatal complications like breast abscess, etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of breast milk pH |
7 days 14 days and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in wight & health of new born |
7 days 14 days & 21 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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Ayurveda
advocates the advantages of Stanya (mother
or wet nurse’s milk) over other feeding options to newborns. Ayurveda considers mother’s milk as ‘Piyush’
or Amrut (nectar) 1[1]. Kashyap
Samhita states that pure breast milk gives unimpeded strength, longevity,
growth, and development to child and also to the mother or wet nurse2 [2]. Modern
science has described
composition of various types of animal milk and has proved that mother’s milk
is suitable for the newborn
as it is digestible and also contains
adequate nutrients. Also, there are no suitable feeding alternatives for
the well-being of infants. |