Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Hydroxychloroquine; Methotrexate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.