| CTRI Number |
CTRI/2026/01/100273 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Boladi vati and Rajapravartini vati in Dysmenorrhea |
|
Scientific Title of Study
|
Boladi vati and Rajapravartini vati in the Management of Udavartini Yonivyapad With Special Refrance to 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 Twinkle varshney |
| Designation |
Prasuti tantra evam stree roga pg scholar |
| Affiliation |
Jeevan Jyoti medical college and hopital lodha aligarh |
| Address |
Room no 203 second floor Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti medical college and hopital lodha lodha aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
7906539056 |
| Fax |
|
| Email |
tvarshney2202@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mamta kumari swain |
| Designation |
HOD and PROFESSOR |
| Affiliation |
Jeevan Jyoti medical college and hopital lodha aligarh |
| Address |
Room no 203 second floor Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti medical college and hopital lodha aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
9348576189 |
| Fax |
|
| Email |
swaindrmamata@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mamta kumari swain |
| Designation |
HOD and PROFESSOR |
| Affiliation |
Jeevan Jyoti medical college and hopital lodha aligarh |
| Address |
Room no 203 second floor Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti medical college and hopital lodha aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
9348576189 |
| Fax |
|
| Email |
swaindrmamata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jeevan Jyoti medical college and hopital lodha aligarh Uttar Pradesh 202140 |
|
|
Primary Sponsor
|
| Name |
Dr Twinkle varshney |
| Address |
Room no 203 second floor Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti medical college and hopital lodha aligarh Uttar Pradesh 202140 |
| 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 Twinkle varshney |
Jeevan Jyoti Ayurvedic Medical College & Hospital Aligarh |
Room no 203 second floor Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti medical college and hopital lodha Aligarh UTTAR PRADESH |
7906539056
tvarshney2202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravartini vati, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Boladi Vati, Reference: Siddhayogasangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patient with chief complaint of painful menstruation at least two consecutive cycles without pelvic pathology |
|
| ExclusionCriteria |
| Details |
1. Patients having Pelvic inflammatory disorder. 2. Patients having anatomical or uterine pathology, fibroid, adenomyosis, cervical stenosis, endometriosis, DUB, Endometrial Polyp etc. 3. Patients suffering from Diabetes, HTN, Thyroid disorder. 4. Patient taking hormonal therapy or IUCD in uterus. 5. Congenital anomalies of reproductive system. 6. PCOD and other medical, surgical, Neurological conditions resulting dysmenorrhoea |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Intensity of Pain and Duration of Pain |
3 Months
The Trail Drug Will be Given for 3 months with Anupana and follow Up Will be After every Menstrual Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Vomiting Tenderness & Headache |
After Analyzing all the Parameters the Result Will be Assessed on the basis of Symptomatic Relief & Improvement
Partially Improvement After 1 Month - Patient get 40-50 percent relief from Sign & Symptoms
Improvement After 2 Month - Patient get 60-80 percent Relief from Sign & Symptoms
After 3 month - Patient get 81-100 percent Relief from Sign & 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)
|
13/01/2026 |
| 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="0" Months="9" Days="10" |
|
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
|
Udavartini yonivyapad is described in modern science as dysmenorrhea, which is more prevalent in young adolescent girls and reproductive aged women . The incidence of dysmenorrhoea is affected generally by social status, occupation and age. Dysmenorrhoea literally means painful menstruation of sufficient magnitude so as to incapacitate day to day activities According to Ayurveda, it is type of yonivyapad which is characterized by pain and difficult expulsion of menstrual blood due to upward movement of raja ( menstrual blood) propelled by vitiated vata. The upward movement is called as Udavrittam. Due to movement of flatus, natural urge in reversible direction, the aggravated Apana vayu moving in reverse direction vitiate yoni. Apana vayu dushit yoni seized the pain, initially throws or pushes the raja upwards, then discharge it with great difficulty. The suffering patient feels relief immediately following discharge of menstrual blood. Hence this condition of raja moves upward or in reverse direction is termed as Udavartini. Besides painful and frothy menstruation, there are other pains of vata According to Ayurveda the major cause of Udavartini is prakupitta vata with viloma gati and thus vata shaman with prakruta gati anuloma gati will solve the problem. Most women experience minor pain during menstruation, dysmenorrhea is diagnosed when the pain is so severe as to limit normal activities. Spasmodic dysmenorrhea can be severe enough to require medication7. Hence the women experiences excessive pain during menstrual cycle. Pain may be accompanied by nausea, vomiting, headaches, and fainting.
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