Rheumatoid arthritis
Conditions
Interventions
control group :Prednisone Acetate Tablets, Methotrexate, Leflunomide
Treatment group No.1:Prednisone Acetate Tablets, Methotrexate, Leflunomide and combined with formula No.1 of chinese medicine
Treatment group No.2:Prednisone Acetate Tablets, Methotrexate, Leflunomide and combined with formula No.2 of chinese medicine
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine / The No.1 Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. According to the ACR rheumatoid arthritis diagnostic criteria of 1987 and TCM diagnostic criteria of wind cold dampness syndrome; 2. Patients with RA disease activity whose DAS28 score is greater than 2.6; 3. Patients who had taken glucocorticoids (prednisone acetate tablets >= 20mg/d or equivalent dose if DAS28 score >= 5.1;Prednisone Acetate Tablets >= 10mg/d or equivalent dose if DAS28 score < 5.1); 4. Aged from 18 to 65 years, male or female; 5. Those who voluntarily participate in the trial and agree to enter the clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. There was a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation disorder, digestive, endocrine, urinary system diseases and malignant tumor before the trial; 2. Patients with bleeding tendency, active gastrointestinal disease and recent history of surgery; 3. There was infection that could not be controlled by antibiotics, and there was a history of severe infection or opportunistic infection 2 months before the trial; 4. Biological agents have been used in recent one month; 5. Pregnant and lactating women; 6. Patients participating in other clinical trials; 7. Allergic constitution (allergic to traditional Chinese medicine, hormone and other experimental drugs); 8. Mental patients; 9. Suspected or true history of alcohol or drug abuse, or other diseases that reduce or complicate the possibility of enrollment,such as frequent changes in working environment, are likely to cause loss of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the frequency of glucocorticoid;the cumulative dosage of glucocorticoid;the relapse rate of disease;Number of joint swelling;Number of joint tenderness;DAS28 score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Curative effect of TCM diseases;TCM syndrome score;Pain VAS scores assessed by patients;VAS score for patient assessment of overall disease status;VAS scores for the overall disease status assessed by the investigator;Health Assessment Questionnaire (HAQ);cortisol;Adrenocorticotropic hormone;Lymphocyte subsets;cytokines;Erythrocyte sedimentation rate;C-reactive protein;Liver function test;Kidney function test;Blood sugar testing;Electrolyte testing;Routine stool test;Routine urine testing;ACR20; | — |
Countries
China
Contacts
Public ContactJiangyun Peng
Yunnan Provincial Hospital of Traditional Chinese Medicine / The No.1 Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Outcome results
None listed