NCT07115641

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

A Multicenter Clinical Randomized Controlled Trial on the Efficacy and Safety of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Huoluo Pills	Huoluo Pills: Orally take 1 pill once, twice a day (swallow with warm water)
DRUG	Iguratimod Tablets	Iguratimod Tablets: Orally take 1 tablet once, twice a day (one tablet in the morning and one in the evening, after meals)

Timeline

• Start date: 2025-08-11
• Primary completion: 2026-05-31
• Completion: 2026-08-31
• First posted: 2025-08-11
• Last updated: 2025-08-11