Clinical Trial of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis

This study aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly assigned to groups). The experimental group will receive oral Huoluo Pills combined with Iguratimod Tablets, while the control group will receive oral Iguratimod Tablets alone. Both groups will be administered continuously for 12 weeks. Primary Efficacy Index: The proportion of ACR20 responders in each group at the end of treatment. Key Secondary Efficacy Index: The change in DAS28 (CRP) score from baseline in each group at the end of treatment. Other Secondary Efficacy Indexes: RF, CRP, ESR, IL - 6, ACR50, ACR70, CDAI, SDAI, HAQ - DI, SF - 36, FACIT - Fatigue, and Traditional Chinese Medicine (TCM) syndrome scores. Safety Indexes: Physical examination, blood routine, urine routine, blood biochemistry, coagulation function, etc. This study will investigate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of RA with Wind - Damp Obstruction or Cold - Damp Obstruction syndromes.

NCT Number	NCT07115641
Lead Sponsor	Wangjing Hospital, China Academy of Chinese Medical Sciences Collaborators: Institute of Science, Beijing Tongrentang Co., Ltd., Beijing Leadingpharm Medicine Technology Development, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan university of CM, Xi'an No.5 Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine
Conditions	Rheumatoid Arthritis
Enrollment	240 participants
Start Date	2025-08-11
Primary Completion	2026-05-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-11