| CTRI Number |
CTRI/2026/03/105662 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| 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
|
Clinical trial to see the effect of Vatahar yog kashay in primary dysmenorrhea that is udavartini yonivyapad |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of vatahar yog kashay orally in the management of udavartini 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 |
Dr Mayuri Dattatraya Ghawate |
| Designation |
PG Scholar Streeroga Prasutitantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga prasutitantra department OPD No 18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7887676673 |
| Fax |
|
| Email |
mghawate05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya Yennawar |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga prasutitantra OPD No 18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9850562524 |
| Fax |
|
| Email |
dryennawar11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayuri Dattatraya Ghawate |
| Designation |
PG Scholar Streeroga Prasutitantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga prasutitantra OPD No 18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7887676673 |
| Fax |
|
| Email |
mghawate05@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Streeroga prasutitantra OPD No 18 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved College Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Depatment of Shalyatantra OPD No 16
Kanchanwadi Chhatrapati Sambhajinagar |
| 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 Mayuri Dattatraya Ghawate |
CSMSS Ayurved Mahavidyalaya And Rugnalaya |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar Depatment of Streeroga Prasutitantra OPD No 18
Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA |
7887676673
mghawate05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved College And Hospital Kanchanwadi Chhatrapati Sambhajinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vatahar yog kashay, Reference: shastrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: 7 days prior and 3 days of menstruation in each cycle for 2 cycle | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: chaturbeeja churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: 7 days prior to menstruation 3 days of menstruation for 2 cycles |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed patients of udavartini yonivyapad
Patients having chief complaints of painful menstruation |
|
| ExclusionCriteria |
| Details |
Patients below 12 and above 24 years
married patients
Patients with pelvic pathology PID PCOD cervical stenosis fibroid endometriosis DUB adenomyosis endometrial polyp
patients taking any hormonal therapy
Patient with congenital anamolies of reproductive system
menorrhagia |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lakshanas of udavartini yonivyapad will decrease |
baseline 30 th and 60 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare effect of vataharyog kashay and chaturbeeja churna |
baseline 30 th and 60 th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/03/2026 |
| 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="6"
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
|
Dysmenorrhoea is painful menstruation of sufficient magnitude so as to incapcitate the day-to-day activities. Dysmenorrhea is commonly classified into Primary and Secondary, in which Primary Dysmenorrhea refers to one is not associated with any identifiable Pelvic pathology. Primary dysmenorrhoea is almost confined to ovulatory cycle and relieved following pregnancy and vaginal delivery. The pain usually appears following painless periods after menarche.
The gynaecological disorders relate with Yoni Vyapadas and are due to the etiology and pathology of the pain is vitiation of vata that causes pain. The incidence of Udavartini Yonivyapad is common today in which Sashool rajpravrutti due to vikrut apan vayu.
Study will be conducted on 100 diagnosed patients of udavartini yonivyapad i.e primary dysmenorrhea
Screening of patients for inclusion
Initial assesment for patient selection
Informed written consent
randomization and group allocation
Trial group(A)-50 patients -vatahar yog kashay
control group(B)-50 patients-chaturbeeja churna
Followup assesment (for maximum 2 months)
Observation and results will be noted
Statistical analysis
Discussion and conclusion |