Rheumatoid Arthritis
Conditions
Interventions
the Treated Group:MTX 10-15mg po qw, and Huayu Qiangshen Tongbi Fang, po qd
the Controled Group:MTX 10-15mg po qw, and LEF 10mg po bid.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. RA is confirmed by the 1987 American College of Rheumatology (ACR) or 2009 ACR Criteria; Imaging results suggest Class I, II or III disease (according to the 1987 American Rheumatism Association (ARA) classification standard); CM inclusion criteria: according to the syndrome of wind and damp stagnation syndrome, or cold and damp stagnation, or hot and damp stagnation, or phlegm and stasis stagnation, or deficiency of Kidney and Liver; 2. Active disease will be assessed by Disease Activity Score (DAS) 28, with DAS28>3.2; 3. Patients aged 18 and 65 years; 4. Informed the damage to the fertility function and still agree to sign the informed consent file and take part in the study; 5. Volunteered for the research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Not meet the diagnostic criteria; 2. Imaging results suggest Class IV disease (according to the ARA classification standard); 3. Unable to provide informed consent; 4. Used in the last month or using glucocorticoids, MTX, hydroxychloroquine, willow nitrogen sulfanilamide pyridine, cyclophosphamide, penicillamine and gold preparations and other immunosuppressive drugs or slow-acting drugs; 5. Participating in another clinical trial; 6. Researchers of this study; 7. Unwilling to comply with treatment or assessment regimen; 8. Unable to comply with treatment or assessment regimen; 9. Severe extra-articular diseases like renal amyloidosis, constrictive pericarditis and so on; 10. Severe co morbid conditions likely to compromise follow up evaluation; 11. Complicated with active gastrointestinal diseases or diagnosed with esophagus or digestive ulcer in the last month; 12. Women currently pregnant, or who are planning on becoming pregnant during the study period; 13. Patients with mental disease; 14. Not suitable to enter this research in the view of the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20/50/70;ESR;CRP;RF;MMP-3;Digital Radiography of both hands;Bone Mineral Density;DAS28; | — |
Secondary
| Measure | Time frame |
|---|---|
| patient report outcome;health assessment qutionnaire; | — |
Countries
China
Contacts
Public ContactQingchun Huang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed