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

NCT ID: NCT02551575

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment of MTX and HCQ

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

Group Type: ACTIVE_COMPARATOR

Treatment of MTX and HCQ

Intervention Type: DRUG

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Treatment of TCM

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

Group Type: EXPERIMENTAL

Treatment of TCM

Intervention Type: DRUG

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks.

Integrative Medicine

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

Group Type: EXPERIMENTAL

Integrative Medicine

Intervention Type: DRUG

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine: 200mg, 3 times a day, oral, for 24 weeks.

Interventions

Treatment of MTX and HCQ

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Intervention Type: DRUG

Treatment of TCM

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks.

Intervention Type: DRUG

Integrative Medicine

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

Hydroxychloroquine: 200mg, 3 times a day, oral, for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

Treatment of MTX, HCQ and Qingre Huoxue placebo; Qingre Huoxue medicines，MTX placebo and HCQ placebo; Treatment of Qingre Huoxue medicines，MTX and HCQ

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Quan Jiang

Director，Devision of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Quan, MD

Role: STUDY_DIRECTOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

Guang'anmen Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Gong X, Liu WX, Tang XP, Wang J, Liu J, Huang QC, Liu W, Fang YF, He DY, Liu Y, Gao ML, Wu QJ, Chen S, Li ZB, Wang Y, Xie YM, Zhang JL, Zhou CY, Ma L, Wang XC, Zhang C, Jiang Q. Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial. Front Pharmacol. 2021 May 25;12:679588. doi: 10.3389/fphar.2021.679588. eCollection 2021.

Reference Type: DERIVED

PMID: 34113254 (View on PubMed)

Other Identifiers

2013BAI02B06

Identifier Type: -

Identifier Source: org_study_id