Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 26, 2026
Date Accepted: Sep 14, 2026
Efficacy of Rajahpravartini Vati in Adolescent and Young Females with Primary Dysmenorrhoea – Protocol for a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial
ABSTRACT
Background:
Primary dysmenorrhea is a prevalent menstrual disorder affecting adolescents and young females worldwide and is associated with substantial impairment in daily functioning, academic performance, psychosocial well-being, and quality of life. Conventional treatments, including nonsteroidal anti-inflammatory and hormonal therapies, often provide temporary symptomatic relief but may cause adverse effects with prolonged use. Rajahpravartini Vati, a classical Ayurvedic herbo-mineral formulation traditionally indicated for painful menstruation, has shown preliminary therapeutic potential but lacks evaluation in a rigorous placebo-controlled clinical trial.
Objective:
This study aims to evaluate the efficacy of Rajahpravartini Vati in adolescent and young females aged 12-24 years with primary dysmenorrhea.
Methods:
This study protocol describes a prospective, double-blind, randomized, placebo-controlled, parallel-group clinical trial to be conducted at the Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh, India. A total of 100 eligible participants will be randomized in a 1:1 ratio to receive either Rajahpravartini Vati (500 mg twice daily) or matched placebo for three consecutive menstrual cycles. Treatment will begin 3 days before the expected onset of menstruation and continue until 3 days after onset, followed by 1 observational cycle. The primary outcome is change in dysmenorrhea severity measured using the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea score. Secondary outcomes include pain intensity and duration, rescue medication use, psychosomatic symptoms, and perceived stress. Both intention-to-treat and per-protocol analyses are planned.
Results:
Ethical approval was obtained on July 16, 2025 (IEC-RARI/2025-26/02). The trial was prospectively registered with the Clinical Trial Registry–India (CTRI/2025/07/091892) on July 28, 2025. Participant recruitment is expected to begin in June 2026, and data collection is anticipated to be completed within 15 months of recruitment initiation.
Conclusions:
This trial is expected to generate evidence regarding the efficacy of Rajahpravartini Vati in managing primary dysmenorrhea among adolescent and young females and may help inform future integrative approaches to menstrual health management. Clinical Trial: Clinical Trial Registry–India: CTRI/2025/07/091892
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