| CTRI Number |
CTRI/2025/11/097265 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison between the Effect of Ksheerbala Taila and Shatapushpa Taila Matrabasti in Managing Primary Dysmenorrhea |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Ksheerbala Taila Matrabasti versus Shatapushpa Taila
Matrabasti in the management of Udavartani Yonivyapad [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 |
Janhvi Pawar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Room Number 09 Department Of Prasuti Tantra and Stree Roga Mahatma Gandhi
Ayurved College Hospital And Research Centre Hirapur Salod
Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284259679 |
| Fax |
|
| Email |
Pawarjanhvi655@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonal Gajbe Raut |
| Designation |
Professor And HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Room Number 09 Department Of Prasuti Tantra and Stree Roga Mahatma Gandhi
Ayurved College Hospital And Research Centre Hirapur Salod
Wardha Maharashtra
MAHARASHTRA
442001
India |
| Phone |
9284259679 |
| Fax |
|
| Email |
Sohum567@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janhvi Pawar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Room Number 09 Department Of Prasuti Tantra and Stree Roga Mahatma Gandhi
Ayurved College Hospital And Research Centre Hirapur Salod
Wardha Maharashtra
MAHARASHTRA
442001
India |
| Phone |
9284259679 |
| Fax |
|
| Email |
Pawarjanhvi655@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE HIRAPUR SALOD WARDHA 442001 MAHARASHTRA INDIA
|
|
|
Primary Sponsor
|
| Name |
Janhvi Pawar |
| Address |
Room Number 09 Department Of Prasuti Tantra and Stree Roga Mahatma Gandhi
Ayurved College Hospital And Research Centre Hirapur Salod
Wardha 442001 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janhvi Pawar |
Mahatma gandhi ayurved college hospital and research centre hirapur salod |
Department of Prasutitantra and Streerog Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9284259679
pawarjanhvi655@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: samhita, Procedure details: 7 days after mensus for 2 consecutive cycle )
(1) Medicine Name: Shatpushpa Tail, Reference: Bhaishjya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: bhaishjya ratnvali, Procedure details: 7 days after menses for two consecutive cycle )
(1) Medicine Name: Ksheerbala tail, Reference: Bhaishjya ratnvali, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing to give written informed consent.Female participants age: 19 to 40 years.Already diagnosed with primary dysmenorrhea (Udavarta Yoni Vyapad). Regular menstrual cycles (21–35 days). |
|
| ExclusionCriteria |
| Details |
Patient having any major or minor systemic disease.
History of secondary Dysmenorrhea due to underlying pathology (e.g., endometriosis,
fibroids) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical parameter of Udavarta Yonivyapad after 4 weeks of completion of trial |
Improvement in clinical parameter of Udavarta Yonivyapad after 4 weeks of completion of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/11/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study compares the effectiveness of Ksheerbala Taila Matrabasti and Shatapushpa Taila Matrabasti in treating Udavartani Yonivyapad or primary dysmenorrhea. It aims to evaluate pain relief and Vata balance through randomized clinical trials establishing a safe evidence-based Ayurvedic treatment for menstrual pain and improved women’s health. |