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

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

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)

Sponsors & Collaborators

• Institute of Science, Beijing Tongrentang Co., Ltd.

  collaborator UNKNOWN

• Beijing Leadingpharm Medicine Technology Development

  collaborator UNKNOWN

• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator OTHER

• The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

  collaborator UNKNOWN

• The First Affiliated Hospital of Henan university of CM

  collaborator UNKNOWN

• Xi'an No.5 Hospital

  collaborator UNKNOWN

• Liaoning University of Traditional Chinese Medicine Affiliated Hospital

  collaborator UNKNOWN

• Affiliated Hospital of Shandong University of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Hospital of Shanxi University of Chinese Medicine

  collaborator UNKNOWN

• Wangjing Hospital, China Academy of Chinese Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-11

Primary Completion

2026-05-31

Completion

2026-08-31