rheumatoid arthritis
Conditions
Interventions
Experimental group:Oral methotrexate 7.5mg qw + 1 sachet of Juanbi Qianggu Granules tid
Control group:Oral methotrexate 7.5mg qw
Sponsors
Shanghai Guanghua Integrated traditional Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Agree to participate in this study and sign the informed consent form; (2) They met the diagnostic criteria for rheumatoid arthritis as defined by the 1987 American College of Rheumatology (ACR) classification criteria and the Chinese medicine industry standard "Diagnostic Efficacy Criteria for Chinese Medicine Evidence" (ZY/T001.1-94) and "Practical Chinese Medicine Rheumatology" (edited by Wang Chengde, Shen Pi'an and Hu Mengqi, People's Health Press, 2009). (2) Inibs with "deficiency of liver and kidney" and the criteria for identifying the disease; (3) Age between 18 and 80 years old (male and female are not limited). (4) 2.6 = DAS28 score <5.1; (5) Chinese medicine symptom score = 6;
Exclusion criteria
Exclusion criteria: (1) Those who have used immunosuppressive drugs within 6 months; (2) Patients with allergies or hypersensitivity to the test drug or patients with serious adverse reactions to the use of the test drug; (3) Patients with serious diseases of the heart, liver, brain, kidney and hematopoietic system (ALT or AST more than 1.5 times the upper limit of normal, blood creatinine level more than 1.5 times the upper limit of normal); (4) Combined tumor or cancer, infectious diseases or with a history of infectious diseases, such as tuberculosis, hepatitis B and HIV carriers, etc; (5) Combination of other rheumatic diseases such as systemic lupus erythematosus, dry syndrome, ankylosing spondylitis, scleroderma, etc; (6) Pregnant or lactating women, psychiatric patients; (7) Patients with advanced rheumatoid arthritis, severe joint deformity, and joint function class IV; (8) Those with a history of opioid analgesics, sedative-hypnotics and alcohol abuse; (9) Those who have received other investigational drugs in the 3 months prior to screening (10) Those who are unable or unwilling to provide informed consent or to comply with the requirements of the trial (11) All subjects who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Global Assessment of Arthritis;Joint damage;Chinese medicine evidence score;Health Assessment Questionnaire – Disability Index;Degree of remission of rheumatoid arthritis disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ultrasound of joints;Joint Magnetic Resonance;Erythrocyte sedimentation rate;C-reactive protein;Cellular inflammatory factor; | — |
Countries
China
Contacts
Public ContactXiao Lianbo
Shanghai Guanghua Integrated traditional Chinese and Western Medicine Hospital
Outcome results
None listed