| CTRI Number |
CTRI/2025/08/092172 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Magdhyadi yoga (Pippali haritaki shunthi) and Karpas beeja churna in Stanyakshaya (lactation insufficiency) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Magdhyadi yoga and Karpas beeja in the management of Stanyakshaya w.s.r to Lactation Insufficiency. |
| 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 Rashmi Jha |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Address |
Room no 25,26 Department of Prasuti Tantra Evum Stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9456958283 |
| Fax |
|
| Email |
rashmijha786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Address |
Room no 25, 26 Department of Prasuti Tantra Evum Stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
| Address |
Room no 25, 26 Department of Prasuti Tantra Evum Stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Jha |
| Address |
Room no 25, 26 Department of Prasuti Tantra Evum Stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rashmi Jha |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
Room no 25, 26 Department of Prasuti Tantra Evum Stree Roga Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131
Bulandshahar
UTTAR PRADESH |
9456958283
rashmijha786@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O924||Hypogalactia. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karpas beeja churna , Reference: Bhavaprakasha nighantu guduchyadi varga shloka no 152, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Magdhyadi yoga , Reference: Harita samhita 3rd sthana chapter-53 shloka no 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -godugdha goghrita gudd), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients with in reproductive age group (18-35 years) from the 5th day postpartum. Patients with a previous Patients us history of lactation deficiency. Both primigravida and multigravida patients. Patients having both caesarean or normal delivery. |
|
| ExclusionCriteria |
| Details |
Patients with major systemic disease like HTN, DM, Thyroid etc Any other major puerperal complication other than lactation insufficiency Women whose babies have cleft palate, cleft lip, or suffer from any congenital debilitating illnesses Any local deformities i.e; Retracted nipple and Breast lump etc |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of stanyamlanta (wrinkled appearance) and baby cry reduces |
1 month
The trial drug will be given for 1 month with anupana and follow up will be done after cessation of medicine i.e. 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of breast feeding increases and no of defecation increases |
After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement
Partially improvement after 2 days patient gets 15-20 percent of relief from sign and symptoms
Improvement after 10 days patient gets 30-40 percent relief from sign and symptoms
Improvement after 15 days patient gets 50-70 percent relief from sign and symptoms
Cured after 30 days patient gets 80-100percent relief from sign and symptoms |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="0"
Months="10"
Days="10" |
|
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
|
After digestion of food first conversion is Rasa dhatu (madhura vipak). Property of rasa dhatu is Madhur.The essence of rasa dhatu from all over the body comes in the breasts and it is called stanya.The loss or suppression of milk in the breasts in women is usually due to anger, grief and the absence of natural affection for her child etc. There are several drugs for Stanyakshaya but Here I have chosen comparative study between two single drugs i.e. Magadhyadi yoga and karpas beeja which does not only treat it’s symptoms but also does samprapti bhanga. Therefore I have selected 60 patients aged between 18-35 years patient should be selected on the basis of inclusion and exclusion criteria. The trial will be of 30 days follow will be done after every week. Cured after 30 days patient gets 80 -100 percent relief from sign and symptoms |