Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The research subjects should meet the following diagnostic criteria: (1) Western medicine diagnostic criteria: the RA classification criteria of the 2010 ACR/EULAR were used for comprehensive judgment; (2) The diagnostic criteria of TCM syndromes refer to the ''Diagnostic Criteria for Syndrome of Rheumatoid Arthritis with Spleen Deficiency and Damp Resistance Syndrome'' (T/CACM1347-2021) issued by the National Chinese Medicine Association in 2021; 2. According to DAS28-CRP score, patients with low disease activity (2.6 <= DAS28-CRP <= 3.2); 3. Aged between 18 and 70 years; 4. Have not received disease-modifying antirheumatic drugs (DMARDs) treatment, or have received DMARD drug treatment in the past, but have not used such drugs for at least the past month; 5. Written informed consent signed by the subjects or their family members (guardians) to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Combined history of other autoimmune diseases, such as Sj?gren's syndrome, systemic lupus erythematosus, etc.; suffering from acute or chronic infectious diseases, including hepatitis B or hepatitis C infection; past history of cancer; evidence of active, latent, or poorly treated Mycobacterium tuberculosis infection; 2. Patients with severe cardiovascular, brain, lung, liver, kidney and hematopoietic diseases; 3. Pregnant patients, lactating patients or patients with known mental disorders; 4. The hemoglobin level is less than 90 g/L, the white blood cell count is less than 3.0x10^9 per liter, or the platelet count is less than 100x10^9 per liter; 5. Patients with glomerular filtration rate less than 40ml/min; 6. The level of aspartate aminotransferase or alanine aminotransferase is 1.5 times higher than the upper limit of the normal range; 7. Patients with active gastroduodenal ulcer or gastritis caused by long-term use of non-steroidal anti-inflammatory drugs; 8. Patients who are allergic to test drugs; 9. Screen patients who participate in other clinical trials within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28 Joint Disease Activity Index-C-Reactive Protein Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rheumatoid factor;Anti-cyclic citrullinated peptide antibody;ESR;C-reactive protein;ACR20 remission rate;Quality of life score;Joint symptoms and signs;Safety;9/5000 X-ray examination of the involved joint; | — |
Countries
China