drugset / Trial / NCT02551575
Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.
Timeline
- Start
- 2014-11
- Primary completion
- 2017-06
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 200 mg | Oral |
| Subject | Methotrexate | Small molecule | 10 mg | Oral |
| Subject | Methotrexate | Small molecule | 15 mg | Oral |
| Subject | Qingre Huoxue external preparation | Traditional medicine (herbal / TCM) | 10 g | Other |
| Subject | Qingre Huoxue granule | Unknown | 10 g | Oral |