Therapeutic evaluation of Rasnadi Gutika and Chandrakala Lepa in Janusandhigata Vata (osteoarthritis knee): A single-arm prospective multicenter clinical study

Abstract

BACKGROUND: Sandhivata [osteoarthritis (OA)] is one of the Vata Vyadhi, which causes much suffering for a prolonged period. The cause of Sandhivata in Ayurveda is attributed to improper diet, lifestyle, and old age, leading to aggravation of Vata, and is associated with slow and steady decline in tissue quality and function. The disease specific symptoms of Sandhigata vata are very similar to that of OA. Treatment in OA is targeted for reviving joint function through halting the disease pathogenesis and promotion of joint health and vitality. OBJECTIVE: The objective of this study was to assess the clinical efficacy of Rasnadi Gutika (RG) and Chandrakala Lepa (CKL) in the management of Janusandhigata Vata [osteoarthritis knee (OA knee)]. MATERIALS AND METHODS: The study was conducted at two peripheral institutes of the Central Council for Research in Ayurvedic Sciences, viz., Central Ayurveda Research Institute, Bhubaneswar, Odisha and Regional Ayurveda Research Institute, Lucknow, Uttar Pradesh. A total of 120 patients between the age of 40 and 75 years suffering from primary OA knee joint were treated with RG and CKL. The duration of the therapy was 12 weeks, and follow-up was done on the 14th, 28th, 42nd, 56th, 70th, and 84th days. RG was administered orally in the dose of 1 g twice daily with lukewarm water, and CKL 10 g was applied locally twice daily for 12 weeks. Parameters such as chief complaints of the disease, viz., joint pain on movement, joint pain at rest, restricted joint, crepitus, swollen joint, stiffness, and bony enlargement; total WOMAC score; and quality of life through WHO QOL BREF score were assessed before and after the administration of therapy. RESULTS: The WOMAC score, the key outcome measure, showed statistically significant improvement (P = 0.001) on the 84th day of follow-up. Improvement was noted in all areas, including pain, stiffness, and physical functioning. The physical health, physiological and social relationships, and environmental areas of the WHO QOL BREF score for quality of life were also significantly influenced (P = 0.0001). No adverse drug reactions or adverse events were reported during the trial period. CONCLUSION: Oral administration of RG and external application of CKL are effective for the management of OA knee. However, further clinical study with sufficient sample size may be required to revalidate this study’s findings.