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CTRI Number  CTRI/2025/06/089385 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 21/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Pathyadi Yog orally will be check in Stanyakshaya 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of pathyadi yog in the management of stanyakshaya 
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 Nikita Panditrao Bahurupi 
Designation  PG Scholar 
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India

Aurangabad
MAHARASHTRA
431011
India 
Phone  7843004802  
Fax    
Email  nikitabahurupi7066@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayashri Shrikant Deshmukh 
Designation  Professor and HOD 
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  9325580777  
Fax    
Email  dr.jayashrisdeshmukh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikita Panditrao Bahurupi 
Designation  PG Scholar  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India

Aurangabad
MAHARASHTRA
431011
India 
Phone  7843004802  
Fax    
Email  nikitabahurupi7066@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
 
Primary Sponsor  
Name  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Address  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita Panditrao Bahurupi  C.S.M.S.S Ayurved Mahavidyalaya, Aurangabad  OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA 
07843004802

nikitabahurupi7066@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O369||Maternal care for fetal problem, unspecified. Ayurveda Condition: STANYAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Haridradi Churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: - Godugdha), Additional Information: -Follow up - 3
2Intervention ArmDrugClassical(1) Medicine Name: Pathyadi Yog, Reference: Harit Samhita Tritiya Sthan ( Shloka No. 53/3,4), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Guda, Ghrita, Godugdha), Additional Information: -Follow up- 3
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Mothers who complain Stanyakshya symptoms after delivery upto 6 months.
2.Age group from 21 years to 40 years.
3.Mother having a 5th day neonate to 12 month baby.
4.Breast milk quantity less than 300ml per day.
5.Patients who will willing to give consent for this study.
 
 
ExclusionCriteria 
Details  1.Known case of Breast abscess, Mastitis, Cracked nipples and Breast cancer.
2.Infant with cleft lip and cleft palate.
3.Mother having a history of hormonal disorder.
4.Patients suffering from Stanyakshaya due to any secondary cause like HIV, TB.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Pathyadi Yog in the management of Stanyakshaya (Hypogalactia).

 
Baseline - 7th, 14th, 21th day  
 
Secondary Outcome  
Outcome  TimePoints 
1.To study Stanyakshaya according to Ayurveda.
2. To study Stanyakshaya according to Modern.
3.To compare the effect of Pathyadi Yog and Haridradi Churna in the management of Stanyakshaya.
 
Baseline - 7th, 14th, 21th day  
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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/ Phase 3 
Date of First Enrollment (India)   07/07/2025 
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="6"
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 is an ancient science which deals with not only the diseased condition but also the normal health of human. In Ayurveda so many Acharya’s explained the importance of Stanya.
         Breast milk is a perfect food for neonates. It is the best gift a mother can give to her baby. Breast feeding is the ideal form of infants feeding. 
Breast milk provides primary source of nutrition for neonates and infants till 6th months. Breast milk is composed of Immunoglobulin IgA, Fat, Proteins, Carbohydrates, Minerals, Digestive enzymes, Antibodies, Lymphocytes. So, Breast milk is best than any other type of feeding. Artificial feeding exposes to the infants leads to gastrointestinal infections like diarrhea, vomiting, sometimes allergic reactions or fever.
         According to Ayurveda Breast milk is the essence of Rasadhatu which is formed from the digested food circulating in the whole body, when it gets collected in breast it is termed as Stanya. As it is formed from Prasad Bhaga of Aahar Rasa it contains best of all nutrients needed for the child. Hence Stanyakshaya is associated with Rasadhatu Kshaya.
The decrease secretion may occur from beginning and continue through entire period of lactation or it may be normal initially and decrease gradually. Keeping these aspects in mind, this study has been undertaken. It is an attempt to verify the claim that Magadhi, Nagari, Pathya are Galactogogue.   
Lactational deficiency is a public concern and major problem worldwide. Therefore, for the management of Stanyakshaya Ayurvedic treatment have multiplied over the recent years which is non hormonal, non-surgical, effective, safer and without any adverse effect.    
Study will conducted on 92 diagnosed patients of Stanyakshaya. Written consent will be taken. Initial assessment will be done. Patients treated with interventional group Pathyadi Yog and control group Haridradi Churna. Patients will be assessed at follow ups. Observations and results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn.
 
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