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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02551575
• Other study ID #: 2013BAI02B06
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: August 26, 2015
• Last updated: June 17, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 468
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Bei Jing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from Baseline to week 24 in Disease Activity Score (DAS28)	Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])	0 weeks, 12 weeks, 24 weeks	No
Secondary	The proportion of patients achieving ACR20/50/70	ACR20/50/70 is referred to American College of Rheumatology Criteria.	0 week, 12 weeks, 24 weeks	No
Secondary	The change from baseline to week 24 in the score on the patient report outcome (PRO)	PRO scores ranges from 0 to 3, with higher scores indicating greater disability	0 week, 12 weeks, 24 weeks	No
Secondary	The change in Sharp score	The change in X-Ray from baseline to week 52.	0 week, 52 weeks	No
Secondary	The change in OMERACT RAMRIS score	The change in Magnetic Resonance Imaging from baseline to week 24.	0 week, 24 weeks	No
Secondary	The number of adverse events	The number of adverse events that are related to treatment	24 weeks	Yes