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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Treatment of TCM; Drug: Treatment of MTX and HCQ; Drug: Integrative Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02551575

2013BAI02B06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 468 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 3 patient groups

Treatment of MTX and HCQ

Active Comparator group

Description:

Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.

Treatment:

Drug: Treatment of MTX and HCQ

Treatment of TCM

Experimental group

Description:

Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.

Treatment:

Drug: Treatment of TCM

Integrative Medicine

Experimental group

Description:

The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.

Treatment:

Drug: Integrative Medicine