Efficacy of Pathyadi Churna and Trikatu Churna in the management of Amavata (rheumatoid arthritis): Protocol for a comparative clinical study

Abstract

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, progressive, systemic autoimmune disease primarily affecting the synovial joints. Clinical symptoms of RA are similar to Amavata- a disease mentioned in Ayurveda. As per the Ayurveda classical texts, the formation and deposition of Ama (biotoxin) play a significant role in the pathogenesis of Amavata (RA). Hence, Deepana (appetite stimulant) & Ama-pachana (interventions that digest the biotoxins) can be first line of treatment for managing RA. Being Deepana and Pachana, Pathyadi Churna and Trikatu Churna can mitigate the Ama, prevent its genesis in the body, and thereby break down the pathogenesis of RA. Both formulations have anti-inflammatory and analgesic action which is supportive while treating RA. The present study will compare the efficacy of Pathyadi Churna and Trikatu Churna in managing RA. MATERIALS AND METHODS: It will be a randomized, parallel-group comparative trial with a sample size of 110 participants. Patients of any gender aged 18 to 65 years diagnosed with Rheumatoid arthritis based on American College of Rheumatology (ACR) 2010 criteria and presenting with Sama clinical features of Amavata will be enrolled in the study. Participants will be divided randomly into two groups. In group I, Pathyadi Churna, and Group II, Trikatu Churna will be administered in 3 gm and 1 gm, respectively, twice daily after food with lukewarm water for four weeks. The efficacy of the study interventions will be assessed through the changes in Disease Activity Score 28 (DAS28) and Ayurvedic disease-specific parameters from baseline. CONCLUSION: The study will help generate evidence regarding the efficacy of Pathyadi Churna and Trikatu Churna in managing RA.