Rheumatoid arthritis
Conditions
Interventions
Therapy group:Decoction A
Placebo group:Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Being positive for anti-CCP (including both anti-CCP and RF positive, or positive anti-CCP with negative RF); 2. With or without arthralgia, can be accompanied by discomfort such as sore, stiffness, numbness or swelling of the joints, but no synovitis was observed; 3. Not fulfilling the 2010 ACR/EULAR RA criteria; 4. No prior DMARDs therapy before screening; 5. Aged 18 to 75 years; 6. Agree to participate in the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of another autoimmune rheumatic disease such as Sjogrens syndrome (also known as sicca syndrome) or systemic lupus erythematosus; acute or chronic infection including hepatitis B or hepatitis C; history of cancer; evidence of active, latent or inadequately treated mycobacterium tuberculosis infection; 2. With severe diseases of the brain, lung, liver, kidney, cardiovascular or hematopoietic system; 3. With diabetes; 4. Pregnant women, breastfeeding mothers, or those with unknown psychiatric disorders; 5. With a hemoglobin level of less than 90 g per liter, a white cell count of less than 3.0 x 10^9 per liter, or a platelet count of less than 100 x 10^9 per liter; 6. With an estimated glomerular filtration rate (eGFR) of 40 ml per minute or less (calculated by the method of Cockcroft and Gault); 7. The aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level higher than 1.5 times the upper limit of the normal range; 8. With an active gastroduodenal ulcer or gastritis caused by the long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs); 9. Being hypersensitive to the trial medication; 10. With synovitis observed by ultrasound prior to inclusion; 11. Use of glucocorticoid before, regardless of oral or topical treatment; 12. Have participated in other clinical trials within 4 weeks of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of rheumatoid arthritis (RA);Time to RA occurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who developed rheumatoid arthritis at different observation nodes;CCP (anti-cyclic citrullinated peptide antibody);RF (rheumatoid factor);DAS28(Disease Activity Score 28);Morning stiffness time;Visual analogue scale (VAS);TJC (tender joint count) 28;SJC (swollen joint count) 28;PhGADA (physician's global assessment of disease activity);PaGADA (patient's global assessment of disease activity);HAQ (health assessment questionnaire);GQLI-74 (generic quality of life inventory 74);Rest pain score;Joint DR(digital radiography);Ultrasound; | — |
Countries
China
Contacts
Public ContactHuang Runyue
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed