Efficacy and Safety of the Bushen Quhan Zhiwang Decoction to Achieve Clinical Deep Remission in Rheumatoid Arthritis: Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial.

Purpose: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by significant disability, with effective management of disease activity and pain constituting critical clinical objectives. The herbal formulation Bushen Quhan Zhiwang Decoction (BQZD) has demonstrated potential efficacy in symptom alleviation, suggesting a promising role in achieving sustained clinical remission in RA. The present study aims to systematically evaluate the efficacy and safety profile of BQZD for managing RA disease activity and pain relief. Patients and Methods: This randomized, double-blind, placebo-controlled, single-center clinical trial will enroll a total of 72 RA patients, randomly assigning them into either the intervention group (n=36) receiving BQZD or the placebo control group (n=36). Participants will consume either BQZD or placebo (100 mL, twice daily) over a 12-week intervention period. Clinical assessments are scheduled at enrollment and subsequently at 4-week intervals, continuing through the 16-week mark post-intervention initiation. The primary outcome measure is the Disease Activity Score for 28 joints (DAS28). Secondary outcome variables include visual analogue scale (VAS) pain scores, mechanical pain threshold (MPT), central sensitization inventory (CSI), patient-reported outcomes (PROs), Traditional Chinese medicine (TCM) symptom scores, and biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Safety endpoints will encompass monitoring of hematological parameters, urinalysis results, and adverse events. Discussion: This study seeks to generate robust clinical evidence verifying the therapeutic efficacy and safety of BQZD for alleviating pain and achieving deep remission in RA patients. These findings are anticipated to facilitate broader integration of traditional herbal medicine within clinical practice. Additionally, this research endeavors to provide clinically relevant insights into precision treatments for RA by integrating traditional Chinese medicine and Western medical approaches, and aims to lay foundational evidence for future investigations into underlying regulatory mechanisms and potential therapeutic targets of TCM.