Multicenter randomized double-blind clinical trial of Qufeng Zhitong capsule combined with methotrexate tablets in the treatment of rheumatoid arthritis

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disorder causing joint damage, functional impairment, and even disability. Qufeng Zhitong (QFZT) capsules with better symptom improvement offer an alternative. This study aims to evaluate the efficacy and safety of QFZT capsules combined with methotrexate in the treatment of RA patients. Methods: This multicenter, randomized, double-blind clinical trial evaluates the efficacy and safety of methotrexate combining with QFZT capsules, in patients with RA diagnosed with cold-dampness Bi-impediment syndrome. A total of 200 participants across 6 clinical sites in China were randomized (1:1) to receive either QFZT (6 capsules/time, twice daily) or placebo, combining with methotrexate (10 mg/wk) for 24 weeks. The main outcome measure is the proportion of patients achieving ACR20 response at week 24. Secondary outcome measures include changes in treatment response (ACR50/70), disease activity (Disease Activity Score-28 for rheumatoid arthritis with C-reactive protein), pain intensity (Visual Analogue Scale), health assessment (Health Assessment Questionnaire-Disability Index), Rheumatoid Arthritis Patient-reported Outcomes, and safety outcomes. Statistical analyses will employ the Cochran–Mantel–Haenszel (χ²) test for the main outcome measure, with adjustments for covariates. Ethics and dissemination: This study has been approved by the Ethics Committee of Guang’anmen Hospital China Academy of Chinese Medical Sciences (Approval Number: 2022-078-YW), and is being conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. The results of the trial will be publicly disclosed in scientific journals or presented at scientific conferences. Discussion: This randomized controlled trial aims to evaluate the efficacy and safety of QFZT capsules combined with methotrexate in treating RA, with its results potentially providing a cost-effective alternative for RA patients inappropriate for biological agents or small-molecule targeted drugs due to economic constraints or poor treatment responses and contributing evidence-based support in autoimmune disease interventions.