| CTRI Number |
CTRI/2025/02/081070 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda Survey Study on Breast Milk pH assessment |
|
Scientific Title of Study
|
A Cross Sectional Study On Stanya Dushti (Breast Milk pH And Foam Test) In Lactating Mothers Of Rural 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 Shubham Patil |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University at post Limda Tehsil Waghodia District Vadodara Gujarat 391760
Vadodara GUJARAT 391760 India |
| Phone |
7030424600 |
| Fax |
|
| Email |
Shubhurpatil1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swapnil C Raskar |
| Designation |
Professor and Head |
| 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 C Raskar |
| Designation |
Professor and Head |
| 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 |
|
|
Source of Monetary or Material Support
|
| Parul University At post Limda Waghodia tehsil District Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Patil |
| Address |
Room 204 Parul Institute of Ayurved Parul University At post Limda tehsil waghodia district Vadodara Gujarat 391760 |
| Type of Sponsor |
Other [PG Study] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Parul University |
Room 204 Parul Institute of Ayurved Parul University Limda Vadodara Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubham Patil |
Parul Institute of Ayurved |
OPD 103 Kaumarbhritya OPD Parul Ayurved Hospital Parul University Vadodara GUJARAT |
7030424600
Shubhurpatil1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
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 to 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 |
| assessment of breast milk pH |
7 days 14 days and 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)
[i][1]. Kashyap
Samhita states that pure breast milk gives unimpeded strength,
longevity, growth, and development to child and also to the mother or wet nurse[ii] [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.
Ayurveda classics have emphasized
on the aspect of abnormalities of breast milk and their consequences on infants
and as well as on mothers. In this pursuit, Ayurveda has a unique theory on
milk vitiation which explains non-suitability of breast milk for infants[iii] [3]. The
theory also describes signs of vitiated milk and its adverse effects on the
infant. This concept too is in accordance with Ayurveda’s theory of three
patho-physiological doshas viz., Vata, Pitta,
and Kapha. These doshas are regulators of
homeostasis if maintained in balanced state by means of appropriate diet and
deeds. Mother’s indulgence in inappropriate diet and in unusual practices can
vitiate doshas and the imbalanced state of doshas in
turn can vitiate breast milk[iv],[v] [3,4,5]. The
vitiated breast milk also affects mother’s health by causing diseases
like jwara [2].
Ayurveda also describes the change in quality of breast milk and the adverse
effects of vitiated milk on the infant[vi] [6].
According to Charaka Samhita, the milk which is normal in colour,
smell, taste, and touch, dissolves completely in water and is wholesome to
infant and can be considered as normal breast milk[vii] [7].
Different Acharyas have mentioned qualities of pure breast
milk and their effect on infants.
1.
Yadavji T., editor. Charaka Samhita, sutrasthanan; annapanavidhi adhyaya. Chaukhambha
Surabharathi Prakashana; Varanasi: 1994. p. 166. Chapter 27, Verse 234.
2.
Tewari P.V., editor. Kashyapa Samhita vriddha jivakiyatantra; sutrasthana. 1st ed.
Chaukhambha Vishwabharati Oriental Publishers; Varanasi: 1996. p. 12. Chapter
19, Verse 26.
3.
Sharma P. In: Yonivyapad
chikitsa adhyaya. Chikitsasthan Charak Samhita., editor.
Chaukambha Sanskrit Pratishana; Delhi: 2006. pp. 781–783. Chapter 30.
4.
Tripathi B., Hrudayam Astanga. Vagbhatta, utara tantra, balaupacharaniya adhyayam. Chaukhambha
Sanskrit Pratishthan; Dehli: 2017. p. 878. Chapter 1 verse 19.
5.
Upadhyaya Y. In: Part
II stanyadushtinidanam. Nidanam Madava, Vibhushitam Madhukosha
Vyakhya., editors. Chaukhambha Prakashan; Varanasi: 2007. p. 450. chapter 67,
Verse 1.
6.
Sharma P., editor. Charak Samhita sharirsthan; jatisutriyasharir adhyaya. Chaukambha
Sanskrit Pratishana; Delhi: 2006. p. 801. [Chapter 08], Verse 54.
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