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

Sponsor
Wangjing Hospital, China Academy of Chinese Medical Sciences
Study ID
NCT07115641
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 11, 2025
Start date
Aug 11, 2025
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trial group
    Huoluo Pills + Iguratimod Tablets
  • Other: Control group
    Iguratimod Tablets

Primary Outcome Measure

The proportion of subjects achieving ACR20 [ Time Frame: At the end of the treatment (on the 84th day) ]

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