Rheumatoid arthritis
Conditions
Interventions
experimental group:ZHENGQING FENGTONGNING sustained release tablets
The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate
Sponsors
The First Affiliated Hospital of Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) to know the whole process of the experiment, voluntarily participate in and sign the informed consent form; 2) in accordance with the 1987 ACR or 2010 ACR rheumatoid arthritis classification criteria for the diagnosis of RA patients; 3) men and women aged 18 to 75 years old; 4) in patients with mild to moderate, 2.6<DAS28 < 5.1 (elevated erythrocyte sedimentation rate (ESR), 28 joint swollen joint count not less than 2, the number of joint pain not less than 3); 5) no severe systemic involvement, such as severe pericardial effusion, pulmonary interstitial disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, and so on.
Exclusion criteria
Exclusion criteria: 1) pregnant women, pregnant or lactating women; 2) liver disease activity period or liver function abnormal, AST, ALT is the upper limit of the normal value 1.5 times or more; 3) renal function damage, blood creatinine is higher than the upper limit of the normal value; 4) the subjects' blood white blood cells < 3 * 10^9/L, or have a clear anemia (hemoglobin is less than 80g/L), or platelet < 80 * 109/L, or have other blood system diseases; 5) with active peptic ulcer disease in recent 1 years; 6) uncontrolled severe hypertension, metabolic diseases (such as diabetes) patients; 7) patients with malignant tumor; 8) suffering from acute and / or chronic infectious diseases; 9) ECG examination of severe arrhythmia; (10) previous use of the drug (positive wind pain Ning, methotrexate) have adverse reactions; 11) have mental disorders, alcoholism, drug or other substance abusers; 12) had a diagnosis of other connective tissue disease; 13) prior use of biological agents, Zhengqingfengtongning, methotrexate or related preparation, discontinuation of <4 weeks; 14) with a variety of other investigators that can not be added to this clinical trial; 15) to participate in other clinical studies in the past 15 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who reached the ACR20 standard at the 24th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects reach DAS28 score of 2.6 or less at each Visit;At each visit the proportion of subjects reach the remission of CDAI and SDAI criteria (CDAI = 2.8, SDAI =3.3);The proportion of subjects who reached the ACR20 standard at each follow-up time;The proportion of subjects who had Rheumatoid factor and anti CCP antibody decreased; | — |
Countries
China
Contacts
Public ContactFANG YONGFEI
The First Affiliated Hospital of Third Military Medical University
Outcome results
None listed