Real-world adherence and tolerability of an Ayurvedic regimen in rheumatoid arthritis: Study protocol for a multicenter, single-arm, open-label clinical study

BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disorder resembling Amavata in Ayurveda , marked by joint inflammation and systemic symptoms. While conventional treatments offer symptomatic relief, long-term adherence, adverse effects, and limited accessibility remain concerns, warranting patient-centered alternatives. Ayurveda outlines multi-modality therapies for Amavata , though real-world evidence on their safety, efficacy, and acceptability is limited. OBJECTIVE: To assess treatment adherence and tolerability of an Ayurvedic regimen in the management of RA. MATERIALS AND METHODS: A multicentric, single-arm, open-label clinical study will be conducted to assess the tolerability, adherence, and safety of Rasnasaptak Kwatha (RSK), Punarnava Guggulu (PG), and Shunthi Churna (SC) in RA patients. A total of 480 participants (120%er) will be enrolled. The intervention comprises PG (1 g thrice daily), SC (1 g twice daily), and RSK (50 mL decoction, twice daily) after meals for 90 days. Primary outcomes include treatment adherence, tolerability, and safety. Secondary outcomes will assess changes in disease activity score 28 based on C-reactive protein scores, joint pain (visual analog scale), tender joint count, morning stiffness duration, health assessment questionnaire disability index, and laboratory biomarkers. Assessments will be conducted at baseline, during, and post-intervention. Outcomes will include adherence and tolerability, along with clinical and laboratory efficacy measures. CONCLUSION: This study is designed to generate real-world evidence on the tolerability, adherence, and effectiveness of a commonly prescribed Ayurvedic regimen comprising RSK, PG, and SC in the management of Amavata . The findings are expected to inform future implementation strategies and support the integration of patient-centered, safe, and feasible Ayurvedic interventions in routine outpatient care for RA. TRIAL REGISTRATION: CTRI/2023/04/051829 dated: April 20, 2023.