Clinical evaluation of Vyoshadi Guggulu and Panchasama Churna in the management of rheumatoid arthritis: An open-label, single-arm, prospective study

Abstract

Abstract BACKGROUND: Rheumatoid arthritis (RA) is a chronic, degenerative disease of the connective tissue, mainly involving the synovial joints, characterized by swelling, pain, and tenderness in multiple joints, associated with morning stiffness, fever, and weakness. RA treatment aims to reduce patients’ clinical symptoms, reduce or prevent joint damage, prevent progression, and improve quality of life. Due to complex RA pathogenesis, multiple interventions are usually required to control the symptoms. Ayurveda offers a wide range of therapeutic interventions that have a potential role in RA. The present study was planned to explore the role of Ayurveda interventions, Vyoshadi Guggulu (VG) and Panchasama Churna (PC), in managing RA. MATERIALS AND METHODS: An open-label, single-arm, prospective clinical study was conducted at Central Ayurveda Research Institute, Bhubaneswar, on 90 trial participants between the ages of 20 and 60 years having the clinical symptoms of RA according to the American College of Rheumatology. The trial drugs, viz., VG 1.5 g (3 tablets of 500 mg each) and PC 3 g, twice daily (in the morning and night after food) with lukewarm water, were administered for 84 days. Paired sample t test was used to compare the mean change in the subjective and objective parameters from baseline day to 84th day. The primary outcome measure was Disease Activity Score-28 (DAS-28), and the secondary outcome measures were Disability Index Score (The Indian Health Assessment Questionnaire), change in acute phase reactants—erythrocyte sedimentation rate (ESR), C-reactive protein, and change in Health Questionnaire short form (SF)-36 score. RESULTS AND DISCUSSION: Data from a total of 89 participants were subjected to statistical analysis, and significant change (P value < 0.001) was observed in the DAS-28 score, Disability Index Score, ESR scoring, and in all the domains of SF-36 Health Survey from baseline day to 84th day. The laboratory assessment parameters, such as liver function test, renal function test, and complete blood count, were within the reference range during the entire study duration, indicating that the interventions VG and PC were safe for the given dose and duration of consumption. CONCLUSION: Based on relief observed in the Ayurveda and modern clinical parameters, DAS-28 score, ESR, and Disability Index Score, it is concluded that VG and PC are effective in the management of RA and were found safe in the given dose and duration of consumption.