JMIR Publications

ABSTRACT

Background:

Ayurveda recommends a comprehensive therapeutic approach for the management of osteoarthritis (OA). However, most of the published clinical studies on Ayurveda interventions for OA management dealt with selected modalities of Ayurveda treatment rather than the holistic therapeutic regimen.

Objective:

This RCT protocol is designed to assess the efficacy and safety of multimodal Ayurveda treatment protocol in the long-term management of primary knee OA compared to standard care.

Methods:

The proposed open-label, parallel-group RCT will be conducted in subjects of any gender aged 40-70 years and diagnosed with primary knee OA as per American College of Rheumatology criteria. Individuals with grade 4 radiographic changes in the affected knee (as per Kellgren-Lawrence classification) and with co-morbidities will not be considered. The study will be conducted at All India Institute of Medical Sciences, New Delhi, India. A total of 150 participants will undergo random assignment in 1:1 ratio to receive either the Ayurveda treatment protocol or the conventional standard care for 180 days. The primary outcome is the change in WOMAC index score from baseline. The secondary outcome measures include the change in the score for pain, stiffness, and physical function from baseline; change in the range of motion of knee joint; change in the score of numeric pain rating scale, Pain Disability Index, and SF-12 questionnaire (to assess health-related quality of life); change in highly sensitive C-reactive protein, interleukin-6, MRI scan and DEXA scan findings; and change in the need of rescue analgesic medication from baseline. The safety will be evaluated by recording the incidence of adverse events and change in liver and kidney function test from baseline.

Results:

The recruitment of study participants initiated on October 11, 2022. To date, we have enrolled 150 participants in the study. The final participant will complete the study by January 31, 2025. We will start analysis of the study outcomes in February 2025, and the publication of final results is expected in the last quarter of 2025.

Conclusions:

This RCT would be the first of its kind study to explore the potential benefits of multimodal Ayurveda regimen (based on Ayurveda principles and scientific evidence) in the long-term management of knee OA through validated subjective, laboratory and imaging parameters. The outcomes of this study can address the needs and challenges associated with OA management. Clinical Trial: Clinical Trial Registry of India - CTRI/2022/05/042792