| CTRI Number |
CTRI/2026/04/107525 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study comparing two Ayurvedic drugs (Nastapushpantak ras and Dashmula Trivrit siddha ghrita pana) in Udavatani Yonivyapad |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate efficacy of Nastapushpantak rasa and Dashumla Trivrit Siddha Ghrita pana in Management of Udavatani Yonivyapad wsr to Primary Dysmenorrhea |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRTI |
| Designation |
PG SCHOLAR |
| Affiliation |
SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA |
| Address |
OPD NO 2 OF PG DEPARTMENT OF PRASUTI TANTRA EVAUM STRI ROGA OF SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA
Mathura
UTTAR PRADESH
281401
India |
| Phone |
7988403076 |
| Fax |
|
| Email |
sainikirti3105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digamber P Shevale |
| Designation |
Professor |
| Affiliation |
SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA |
| Address |
OPD NO 2 OF PG DEPARTMENT OF PRASUTI TANTRA EVAUM STRI ROGA OF SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA
Mathura
UTTAR PRADESH
281401
India |
| Phone |
9271232369 |
| Fax |
|
| Email |
digs198180@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digamber P Shevale |
| Designation |
Professor |
| Affiliation |
SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA |
| Address |
OPD NO 2 OF PG DEPARTMENT OF PRASUTI TANTRA EVAUM STRI ROGA OF SHRI DHANWANTARI AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE MATHURA
Mathura
UTTAR PRADESH
281401
India |
| Phone |
9271232369 |
| Fax |
|
| Email |
digs198180@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI DHANWANTRI AYURVEDIC COLLEGE AND RESEARCH CENTER MATHURA UP 281401 |
|
|
Primary Sponsor
|
| Name |
SHRI DHANWANTRI AYURVEDIC COLLEGE AND RESEARCH CENTER |
| Address |
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA SHRI DHANWANTRI AYURVEDIC COLLEGE AND RESEARCH CENTER MATHURA 281401 |
| 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 |
| KIRTI |
SHRI DHANWANTRI AYURVEDIC COLLEGE AND RESEARCH CENTER |
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA SHRI DHANWANTRI AYURVEDIC COLLEGE AND RESEARCH CENTER MATHURA 281401
Mathura
UTTAR PRADESH |
7988403076
sainikirti3105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICE Shri Dhanwantri Ayurvedic Medical College and Research Center Mathura ,Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, University,UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nastapushpantak rasa, Reference: Bhaishaijya Ratnawali chapter 67 Shloka 51-57, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: Drug duration should be starting 7 days before commencement of menstrual cycle till 3rd day of bleeding phase for 3 consecutive cycle | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmula Trivrit Siddha Ghrita pana, Reference: Asthanga Sangraha Uttara Tantra 39/42, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Kwsona jala), Additional Information: Drug duration should after each menstrual cycle for 3 consecutive cycle |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients with signs and symptoms of udavartani yonivyapad as described in ayurvedic text
2 Females suffering with painful menstruation for 3 consecutive cycles
3 Female age group 13 to 25 |
|
| ExclusionCriteria |
| Details |
1 Cases of secondary dysmenorrhea with pelvic pathology
2 patient using IUCD
3 Patient having systemic disease likely to influence menstrual cycle
4 Patient having congenital anomalies leading to dysmenorrhea |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in udavartani yonivyapad symptoms |
Change in udavartani yonivaypad symptoms after 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant changes in symptoms of Udavartani yonivyapad and also adverse events experienced by participants |
3 consecutive cycles |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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
|
From this study it is expected that the end of the study will be able to demonstrate the comparative effect of Nastapuspantak Rasa and Dashmula Trivrit Sidhha Ghrita Pana in Management of Udavartani Yonivyapad wsr to Primary Dysmenorrhea .It is further expected that this study will be able to provide the information related to the safety and efficacy of Nastapuspantak Rasa and Dashmula Trivrit Sidhha Ghrita Pana in Management of Udavartani Yonivyapad wsr to Primary Dysmenorrhea. |