Increasing Effect and Decreasing Toxicity of TCM treatment for Active Rheumatoid Arthritis: An Evidence-based Evaluation Study
Phase 1
- Conditions
- Rheumatoid Arthritis
- Registration Number
- ITMCTR1900002464
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Compliance with the 2010 ACR/EULAR RA classification criteria;
2. DAS28 3.2 - 5.1;
3. RA patients who Compliance with the syndrome of spleen deficiency and dampness toxic stasis obstruction;
4. Disease course <=24 months;
5. Aged18 to 65 years old;
6. The patient was informed and agreed to participate in the study.
Exclusion Criteria
1. Patients with severe organ disease or mental illness;
2. Patients who are allergic to the drugs involved in the study protocol or who have contraindications.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DAS28 remission rate;DAS28 Low activity rate;EULAR response standard;
- Secondary Outcome Measures
Name Time Method Sharp van der Heijde score;HAQ-DI;physician's global assessment of disease activity, MDGA;Simplified disease activity index, SDAI;TCM syndrome score;patient's global assessment ofdisease activity, PGA;Visual Analogue Scale/Score, VAS;FACIT-Fatigue;Clinical disease activity index, CDAI;CDAI remission rate;Incidence rate;RA color Doppler ultrasound joint semi-quantitative score;SF-36;SDAI remission rate;