Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments treatment of mtx and hcq, treatment of tcm, integrative medicine
Phase phase 2/phase 3
Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Start date November 2014
End date June 2017
Trial size 468 participants
Trial identifier NCT02551575, 2013BAI02B06

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.
treatment of mtx and hcq Treatment of MTX, HCQ and Qingre Huoxue placebo
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.
(Experimental)
Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.
treatment of tcm Qingre Huoxue medicines,MTX placebo and HCQ placebo
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.
(Experimental)
The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.
integrative medicine Treatment of Qingre Huoxue medicines,MTX and HCQ
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.

Primary Outcomes

Measure
The change from Baseline to week 24 in Disease Activity Score (DAS28)
time frame: 0 weeks, 12 weeks, 24 weeks

Secondary Outcomes

Measure
The proportion of patients achieving ACR20/50/70
time frame: 0 week, 12 weeks, 24 weeks
The change from baseline to week 24 in the score on the patient report outcome (PRO)
time frame: 0 week, 12 weeks, 24 weeks
The change in Sharp score
time frame: 0 week, 52 weeks
The change in OMERACT RAMRIS score
time frame: 0 week, 24 weeks
The number of adverse events
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.