NCT04170504

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than Qing Re Huo Xue placebo combined with MTX for patients with active rheumatoid arthritis (RA).

Detailed description

To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10g bid and MTX 10mg once a week for 24 weeks, or MTX plus QRHX placebo. The primary outcome is the bone marrow edema score in Outcome Measures in Rheumatology Clinical Trials RA MRI Scoring (OMERACT-RAMRIS) at week 24.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Qing Re Huo Xue (QRHX) granule	Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks
DRUG	Methotrexate	Oral methotrexate 10 mg per week for 24 weeks.
DRUG	Qing Re Huo Xue (QRHX) granule placebo	Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks

Timeline

• Start date: 2019-11-14
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2019-11-20
• Last updated: 2024-09-23

Locations

1 site across 1 country: China