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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Other 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 | 2 | Intervention Arm | Drug | Classical | | (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. |