Efficacy of a Multimodal Ayurveda Regimen in the Management of Primary Knee Osteoarthritis: Protocol for an Open-Label Randomized Controlled Trial.

Background: Ayurveda recommends a comprehensive therapeutic approach for osteoarthritis management. However, most of the published clinical studies on Ayurveda interventions for osteoarthritis management have addressed selected modalities of Ayurveda treatment rather than the holistic therapeutic regimen.

Objective: This study aimed to assess the efficacy and safety of a multimodal Ayurveda treatment protocol in the long-term management of primary osteoarthritis of the knee compared with standard care.

Methods: The proposed open-label, parallel-group randomized controlled trial was conducted in individuals of any gender aged 40 to 70 years and diagnosed with primary osteoarthritis of the knee as per the American College of Rheumatology criteria. Individuals with grade 4 radiographic changes in the affected knee (based on the Kellgren-Lawrence classification) and with comorbidities were not considered. The study was conducted at the All India Institute of Medical Sciences, New Delhi, India. A total of 150 participants underwent random assignment in a 1:1 ratio to receive either the Ayurveda treatment protocol or conventional standard care for 180 days. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index score from baseline. The secondary outcome measures included the change in the score for pain, stiffness, and physical function from baseline; change in the range of motion of the knee joint; change in the score of the numeric pain rating scale, Pain Disability Index, and 12-item short-form survey questionnaire (to assess health-related quality of life); change in highly sensitive C-reactive protein levels, interleukin-6 levels, magnetic resonance imaging scan findings, and dual-energy X-ray absorptiometry scan findings; and change in the need for rescue analgesic medication from baseline. Safety was evaluated by recording the incidence of adverse events and changes in liver and kidney function tests from baseline.

Results: Recruitment of study participants commenced on October 11, 2022. Currently, all the participants completed the study and the analysis of the study outcomes is ongoing.

Conclusions: This randomized controlled trial will be the first study to explore the potential benefits of a multimodal Ayurveda regimen (based on Ayurveda principles and scientific evidence) in the long-term management of osteoarthritis of the knee through validated subjective, laboratory, and imaging parameters. The outcomes of this study may address the needs and challenges associated with osteoarthritis management.

Trial Registration: Clinical Trial Registry of India CTRI/2022/05/042792; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njk0MTM=&Enc=&userName=.

International Registered Report Identifier (irrid): DERR1-10.2196/68306.