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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Lactating Mothers  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator Arm (Non Ayurveda)-NILNIL
 
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., VataPitta, 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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