Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Treatment of MTX and HCQDrug: Treatment of TCMDrug: Integrative Medicine
- Registration Number
- NCT02551575
- Brief 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.
- Detailed Description
Three arms were included in this study, and treatment with MTX and HCQ is defined as active comparator. Treatment of TCM，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX placebo and HCQ placebo, is defined as one experimental arm. Treatment of integrative medicine，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX and HCQ, is defined as another experimental arm.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 468
- Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria.
- Diagnosed with TCM dampness heat and blood stasis syndrome
- The course of RA is not more than 5 years.
- Swollen joint (SJC)≥2 and tender joint count(TJC)≥3.
- Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr
- Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study.
- Age 18-65 years with informed consent
- Patients with skin burst or allergies.
- Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
- Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
- Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
- Previous treated with MTX or HCQ
- Patients with retinopathy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment of MTX and HCQ Treatment of MTX and HCQ Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo. Treatment of TCM Treatment of TCM Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo. Integrative Medicine Integrative Medicine The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.
- Primary Outcome Measures
Name Time Method The change from Baseline to week 24 in Disease Activity Score (DAS28) 0 weeks, 12 weeks, 24 weeks Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])
- Secondary Outcome Measures
Name Time Method The proportion of patients achieving ACR20/50/70 0 week, 12 weeks, 24 weeks ACR20/50/70 is referred to American College of Rheumatology Criteria.
The number of adverse events 24 weeks The number of adverse events that are related to treatment
The change from baseline to week 24 in the score on the patient report outcome (PRO) 0 week, 12 weeks, 24 weeks PRO scores ranges from 0 to 3, with higher scores indicating greater disability
The change in Sharp score 0 week, 52 weeks The change in X-Ray from baseline to week 52.
The change in OMERACT RAMRIS score 0 week, 24 weeks The change in Magnetic Resonance Imaging from baseline to week 24.
Trial Locations
- Locations (1)
Guang'anmen Hospital
🇨🇳Bei Jing, Beijing, China