Clinical evaluation of Indukanta ghrita and Trayodashanga guggulu in the management of rheumatoid arthritis: A prospective open-label single-arm multicentric clinical trial

Abstract INTRODUCTION: Rheumatoid arthritis (RA) is a systemic autoimmune disease primarily characterized by inflammatory arthritis and accompanied by extra-articular manifestations. Interaction of the genetic and environmental factors is a widely accepted cause of this autoimmune disorder. The present study has been designed to evaluate the safety and therapeutic effect of Indukanta ghrita (IG) and Trayodashanga guggulu (TG) in the management of RA. MATERIALS AND METHODS: This open-label, single-arm clinical study was conducted at two centers—National Ayurveda Research Institute for Panchakarma, Cheruthuruthy and Central Ayurveda Research Institute, Kolkata—with a total of 100 participants aged 20–60 years diagnosed with adult-onset RA. The intervention consisted of 10 g of IG administered before meals and 1.5 g of TG (three 500 mg tablets) administered after meals, both given orally with lukewarm water twice daily for a duration of 12 weeks. Participants were followed up every 15 days throughout the intervention period. The primary outcome measure was the mean change in Disease Activity Score-28 (DAS-28). Secondary outcomes included changes in the Health Assessment Questionnaire Disability Index, acute phase reactants (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]), quality of life (QoL) assessed by the SF-36 Health Survey Questionnaire, and the incidence of any adverse drug reactions or adverse events. RESULTS: Out of the 100 participants enrolled, data from 86 subjects were included in the final analysis. A statistically significant reduction in the DAS-28 score was observed over the 12-week period decreasing from a baseline value of 5.35 ± 1.43 to 4.18 ± 1.49 ( P < 0.001), indicating reduced disease activity. Significant improvements were also noted in the disability index ( P < 0.001) and all domains of QoL assessed by the SF-36 Health Survey, including physical functioning, emotional well-being, pain, and energy levels ( P < 0.001). Core clinical symptoms of RA such as joint pain, morning stiffness, tenderness, swelling, fever, and malaise showed marked reduction, with morning stiffness decreasing by 33.7% and malaise by 34.8% from baseline to the end of the study. Hematological and biochemical parameters were within the reference range throughout the study period. CONCLUSION: The study findings suggest that the combination of IG and TG, administered over 12 weeks, is effective in reducing disease activity and improving functional status and QoL in patients with adult-onset RA. TRIAL REGISTRATION: CTRI/2018/07/015025 dated July 24, 2018.