| CTRI Number |
CTRI/2025/07/091892 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to find if Rajahpravartini Vati can provide relief in painful periods in 12 to 24 years old females |
|
Scientific Title of Study
|
Efficacy of Rajahpravartini Vati in Adolescent and Young Females with Primary Dysmenorrhoea – Double-blind Randomized Placebo-controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS-RARI, Itanagar, Arunachal Pradesh |
| Address |
Room No.13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS-RARI, Itanagar, Arunachal Pradesh |
| Address |
Room No.13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS-RARI, Itanagar, Arunachal Pradesh |
| Address |
Room No.13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (Under Ministry of Ayush, Government of India), 61-65, Opposite D-Block, Janakpuri Institutional Area, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Regional Ayurveda Research Institute |
| Address |
Near Mithun Gate, Itanagar-791111, Arunachal Pradesh |
| Type of Sponsor |
Research institution |
|
|
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 Arvind Kumar |
Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh |
OPD Room No. 4, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar-791111
Papum Pare
ARUNACHAL PRADESH |
9660033435
dr.arvindaggarwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC RARI ITANAGAR |
Approved |
| IEC RARI ITANAGAR |
Approved |
|
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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 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo Tablets - 500 mg BID after food with lukewarm water, starting from 3 days prior to the expected date of onset of menstrual bleeding till the completion of 3 days from the onset of bleeding, for 3 Menstrual Cycles | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajahpravartini Vati, Reference: API-AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: The intervention will start from 3 days prior to the expected date of onset of menstrual bleeding till the completion of 3 days from the onset of bleeding, for 3 Menstrual Cycles |
|
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1. Menstruating females aged between 12 to 24 years.
2. Females who has never given birth to a live child (Nulliparous).
3. Females who has completed at least 1 year from the date of menarche.
4. Females with self-reported history of pain associated with menstruation for at least 3 out of last 6 menstrual cycles.
5. Females with the history of regular menstrual cycles (equal or less than 9 days variation between shortest & longest cycle) of 24 to 38 days length with bleeding duration of equal or less than 8 days & normal flow during last 3 cycles. 6. Females willing to participate in the study and agreeing to provide written informed assent and/or consent (as applicable) for participation in the study for next 5 months. |
|
| ExclusionCriteria |
| Details |
1. Females with known/pre-diagnosed/having the history of (during the past 6 months) Gynaecological or pelvic pathologies, e.g. Uterine fibroids, gynecological malignancy, female hormonal disorders, PCOD, endometriosis, pelvic inflammatory disease, metrorrhagia, menorrhagia, leucorrhoea, gynaecological surgery, etc.
2. Females with known/pre-diagnosed/having the history of (during the past 6 months) systemic disorder likely to impact the menstrual physiology, e.g. Thyroid dysfunction, mental disorder, and moderate anaemia (Hb less than 10 gm percent), etc.
3. Females with known/pre-diagnosed/having the history of (during the past 6 months) Hypertension and diabetes mellitus.
4. Females with known/pre-diagnosed/having the history of (during the past 6 months) - Hepatic impairment defined as raised serum SGOT, SGPT, and total bilirubin more than 2 times of upper normal limits.
5. Females with known/pre-diagnosed/having the history of (during the past 6 months) Renal impairment defined as serum creatinine above the normal limit.
6. Females diagnosed with any of the above conditions during screening laboratory test by Serum SGOT, SGPT, Total-Direct-Indirect Bilirubin, Creatinine, FBS, Serum TSH, Hb percentage, & clinical assessment.
7. Females suffering with persistent pelvic pain throughout the menstrual cycle.
8. Females with pre-diagnosed concurrent neurological, pulmonary, endocrine, or unstable cardio-vascular disease.
9. Females currently using or having the history of using any intrauterine device, and/or taking oral contraceptive pills during last 3 cycles.
10. Females planning to conceive within the next 6 months.
11. Females on prolonged medication for any other medical condition. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in severity of primary dysmenorrhoea assessed by change in ‘WaLIDD’ score. |
At baseline, 1st, 2nd, 3rd, and 4th cycle. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in duration and intensity of pain (12 hourly) associated with primary dysmenorrhoea assessed by change in ‘VAS’ score. |
At baseline, 1st, 2nd, 3rd, and 4th cycle. |
| Change in frequency of rescue medicine use. |
At the end of 4th cycle. |
| Change in psychosomatic status assessed by the change in ‘Moos Menstrual Distress Questionnaire’ score. |
At baseline, 3rd & 4th cycle. |
| Change in perceived stress level assessed by the change in ‘Perceived Stress Scale (10 Items)’ score. |
At baseline, 3rd & 4th cycle. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="2"
Months="3"
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
|
Study Title: Efficacy of Rajahpravartini Vati in Adolescent and Young Females with Primary Dysmenorrhoea – Double-blind Randomized Placebo-controlled Clinical Trial Primary Purpose: To evaluate whether Rajahpravartini Vati, an Ayurvedic formulation, is more effective than placebo in reducing the severity of primary dysmenorrhea in adolescent and young females aged 12-24 years. Study Hypothesis: Rajahpravartini Vati is superior to placebo in reducing the severity of primary dysmenorrhea among adolescent and young females. Study Design: This is a Phase III, randomized, double-blind, placebo-controlled clinical trial with 1:1 allocation ratio, to be conducted at the Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh. Sample Size: 100 participants (50 in each group) Primary Outcome: Change in severity of primary dysmenorrhea assessed using the WaLIDD (Working ability, Location, Intensity, Days of pain, Dysmenorrhea) score measured at baseline and after 1st, 2nd, 3rd, and 4th menstrual cycles. Treatment Duration: RPV or placebo tablets (500mg twice daily) administered from 3 days before expected menstruation until 3 days after onset of bleeding, for 3 consecutive menstrual cycles, with one follow-up cycle. Rationale: Previous studies on RPV for dysmenorrhea had methodological limitations. This robust double-blind, placebo-controlled trial aims to provide high-quality evidence for RPV’s efficacy in managing primary dysmenorrhea, potentially offering an effective Ayurvedic alternative for this common condition affecting young women’s quality of life. |