Efficacy of Rajahpravartini Vati in Adolescent Girls and Young Women With Primary Dysmenorrhea: Protocol for a Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

BackgroundPrimary dysmenorrhea is a prevalent menstrual disorder affecting adolescents and young women 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 herbomineral formulation traditionally indicated for painful menstruation, has shown preliminary therapeutic potential but lacks evaluation in a rigorous placebo-controlled clinical trial.ObjectiveThis study aims to evaluate the efficacy of Rajahpravartini Vati in adolescent girls and young women aged 12 to 24 years with primary dysmenorrhea.MethodsThis 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 a matched placebo for 3 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 the 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.ResultsThe study was sanctioned in July 2025, and the first installment of funds was released in September 2025. Ethics approval was obtained on July 16, 2025 (IEC-RARI/2025-26/02), and the trial was prospectively registered with the Clinical Trial Registry-India (CTRI/2025/07/091892) on July 28, 2025. Participant recruitment began in June 2026, and is ongoing. To date, 15 participants had been screened, 6 enrolled, and 9 were classified as screen failures. Data analysis has not yet commenced, and results are expected to be available for publication in 2028.ConclusionsThis trial is expected to generate evidence regarding the efficacy of Rajahpravartini Vati in managing primary dysmenorrhea among adolescent girls and young women and may help inform future integrative approaches to menstrual health management.