Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 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 10mg bid and MTX 10 mg once a week for 24 weeks, or MTX plus dummy QRHX. The primary outcome is he OMERACT rheumatoid arthritis MRI scoring system (RAMRIS) at week 24.

Tracking Information

NCT #
NCT04170504
Collaborators
Not Provided
Investigators
Principal Investigator: Quan Jiang, M.D Guang' anmen hospital