| CTRI Number |
CTRI/2025/03/083093 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY OF YONI SHOOLAHAR KASHAYA AND TRIVRITA TAILA MATRA BASTI IN pain during menstrual cycle. |
|
Scientific Title of Study
|
CLINICAL STUDY OF YONI SHOOLAHAR KASHAYA AND TRIVRITA TAILA MATRA BASTI IN KASHTARTAVA (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 |
DR SAROJ CHOUDHARY |
| Designation |
P. G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09660339923 |
| Fax |
|
| Email |
choudharysaroj786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Associate professor |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09166607559 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAROJ CHOUDHARY |
| Designation |
P. G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09660339923 |
| Fax |
|
| Email |
choudharysaroj786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Deoartment of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Saroj Choudhary |
P G Deoartment of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAROJ CHOUDHARY |
Sanjeevni hospital DSRRAU jodhpur |
Room no 05 P G Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
9660339923
choudharysaroj786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate Instiute of Ayurved, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yoni shoolhar kashaya, Reference: sahstrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: madhu and sarkra), Additional Information: nil | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: charak samhita chikitsasthan , Procedure details: Purvakarma- Abhyanga (Specially over abdomen, back) followed by
Swedana done to the patient.)
(1) Medicine Name: Trivrit tail, Reference: Charak samhita chikitsa sthan 30/110-111, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with chief complaint of pain during menses along with associated symptoms.
2. Patients who have menstrual pain score more than Grade I according to verbal multidimensional scoring system VMSS.
3. Patients who had regular menstrual cycles of 28-35 days in the last 3 months.
4. Patients in age group of 15 to 35 years.
5. Patients with H/o using analgesics during menses. Patient willing to give voluntary informed consent for the study |
|
| ExclusionCriteria |
| Details |
1. The patient suffering from any severe systemic, or autoimmune disorders, especially those who are mentioned as Asadhya Vyadhi as per clinical text of Ayurveda will be excluded.
2. Subjects having organic pathology of uterus and adnexa like Fibroid uterus, carcinoma of endometrium, endometriosis.
3. Patients with anatomical defects of reproductive tract.
4. Patients having pelvic inflammatory disease or chronic leucorrhoea.
5. Known case of thyroid & DM
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Normal menstrual cycle without pain. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in associated features like Vomiting, Headache and Diarrhoea. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/04/2025 |
| 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="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
|
This is open label single group clinical study to evaluate the effect of Yoni shoolahar kashaya and Trivrita taila matra basti in the management of kashtartava (Primary Dysmenorrhea). |