Effectiveness of Composite Ayurveda Regimen in a Black Box Design for the Management of Rheumatoid Arthritis: Protocol of a Single Arm, Community-Based Study.

Background: Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. RA usually tends to be progressive and leads to substantial health care burdens, both in terms of disability and economic costs. Despite the various treatment modalities available, there is still an urgent need for safe and effective medicine based on the pattern of disease presentation. The increasing interest in complementary and alternative medicine has created a demand for extensive research in this area.

Objective: This clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA.

Methods: The study is a single-arm (pre-post design), community-based interventional study with a black box design being conducted at 6 study centers. A total of 240 participants aged between 18 and 65 years, diagnosed with RA as per the 2010 American College of Rheumatology and the European League Against Rheumatism criteria are recruited as per the selection criteria. All the participants received Ayush-SG and Rasnasaptak Kashaya for 84 days along with customized treatment as per the disease presentation and associated complaints. The outcome measures include the change in disease activity score (DAS)-28 with erythrocyte sedimentation rate, disease-specific biochemical and inflammatory markers, Disability Index score, change in the participant's assessment of pain and frequency of use of conventional analgesics or nonsteroidal anti-inflammatory drugs from baseline. The tolerability of interventions is assessed through the occurrence of adverse events. Categorical variables will be analyzed with McNemar chi-square test, and continuous variables will be assessed using the paired t test or Wilcoxon test for pre-post assessment. The level of significance will be 5%.

Results: The recruitment of participants was initiated in December 2023. The participant recruitment was completed in March 2024 and out of 240 participants enrolled, 222 (92.5%) completed the study up to the last follow-up. Data verification, compilation, and analysis are under process. After data analysis, the study's findings will be published in a peer-reviewed journal.

Conclusions: This interventional study that incorporates the black box approach may provide a strong framework for managing RA. This design is a more reliable method for evaluating the effectiveness and tolerability of the composite Ayurveda regimen in RA.

Trial Registration: Clinical Trial Registry-India CTRI/2023/06/054203; https://tinyurl.com/4prvwr6z.

International Registered Report Identifier (irrid): DERR1-10.2196/57918.