Yikun He,1,* Jiaying Shen,1,* Huihui Wu,1,* Lan Chen,2 Qian Zhou,3 Qi Wang,4 Yafang Guo,5 Fan Wu,6 Xin Pan1 

1Department of Rheumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People’s Republic of China; 2Department of Traditional Chinese Medicine, Shanghai Sanlin Kangde Community Health Service Center, Shanghai, 200124, People’s Republic of China; 3Department of Traditional Chinese Medicine, Shanghai Nanmatou Community Health Service Center, Shanghai, 200127, People’s Republic of China; 4Department of Traditional Chinese Medicine, Shanghai Punan Hospital of Pudong New District, Shanghai, 200125, People’s Republic of China; 5Department of Traditional Chinese Medicine, Shanghai Pudong Hospital Affiliated to Fudan University, Shanghai, 201399, People’s Republic of China; 6Ultrasound Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Fan Wu, Email wufan12cn@qq.com Xin Pan, Email panxin66@163.com

Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Among the currently available therapeutic agents, methotrexate (MTX) is an internationally recognized first-line disease-modifying antirheumatic drug (DMARD) for RA and is widely used as a basic drug in combination therapies. The Bushen Jiedu Tongluo Decoction (BSJDTL), an herbal formula, has been used for the treatment of RA for more than ten years with a better curative effect. Therefore, we designed a multi-center, randomized, double-blind, placebo-controlled study, to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA.
Methods: This was a multi-center, randomized, double-blind placebo-controlled trial. A total of 120 adult participants with active RA will be enrolled, with a balanced treatment allocation (1:1). The treatment intervention will be BSJDTL plus the conventional medicine methotrexate, and the control intervention will be placebo plus the conventional drug methotrexate for 24 weeks. In addition, both groups received folic acid during treatment to prevent side effects of methotrexate. The primary outcome was DAS28-ESR. Secondary outcomes included changes in joint symptoms and signs, ESR, CRP, MIF, MMP2, CD147, ICAM-1, VCAM-1, and HIF-1α levels, and joint evaluation via musculoskeletal ultrasound and X-ray.
Discussion: We designed this multi-center, randomized, double-blind, placebo-controlled clinical trial, utilizing assessment of RA activity and imaging techniques (musculoskeletal ultrasound and X-ray) to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. The results of this trial may provide insights into improving the clinical symptoms of patients with RA. We hope that this trial will provide preliminary evidence of the efficacy of BSJDTL in treating RA patients and that these results will aid researchers, practitioners, and patients alike.
Aim: This study aimed to clarify the efficacy and safety of BSJDTL in patients with active RA.
Trial Registration: International Traditional Medicine Clinical Trial Registry, ITMCTR2025000194.

Keywords: Bushen Jiedu Tongluo Decoction, efficacy, rheumatoid arthritis, randomized double-blind controlled clinical trial