Rheumatism
Conditions
Interventions
the control group:???
The treatment group:???
Sponsors
Yunnan Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) It meets the classification standard of rheumatoid arthritis in western medicine: RA classification standard and scoring system jointly formulated by ACR and eular2 in 2010; (2) Meet the syndrome differentiation standard of Qi Bi (mixed cold and heat syndrome) in traditional Chinese medicine; (3) 18-70 years old (including 18 and 70 years old), male and female; (4) Patients using biological DMARDs need to stop the drug for 30 days; (5) The drug dose of patients treated with oral glucocorticoid was stable for at least 30 days before entering the study, and the oral dose was = 10mg; (6) The joint function was in grade ? - ?; (7) 2.6 points < DAS28 = 5.1 points; (8) Those who voluntarily participate in the trial, agree to enter the clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Before the test, there was a history of serious respiratory, blood circulation, digestive tract, endocrine, urinary system diseases and malignant tumors; (2) In the late stage of RA, patients with severe joint deformity, joint function in stage IV, X-ray stage in stage III; (3) Overlap patients with other rheumatic diseases such as ankylosing spondylitis, Sjogren's syndrome and systemic lupus erythematosus; (4) Patients receiving biological DMARDs other than methotrexate; (5) During screening, the relevant laboratory indexes were abnormal, the total number of leukocytes was less than 3.5x109/l, the serum creatinine exceeded the upper limit of normal by 1.5 times, and the alanine aminotransferase or aspartate aminotransferase = 2 times the upper limit of normal value; (6) Those who are participating in other drug clinical trials, or the group of drug clinical trials is less than 1 week; (7) Patients who fail to complete drug treatment according to the doctor's advice, unable to judge the curative effect, poor compliance, or incomplete data; (8) Allergic constitution (known to be allergic to the components of this drug); (9) Pregnant, lactating or pregnant women; (10) History of neuropsychiatric abnormalities (epilepsy, depression, etc.); (11) Suspected or true history of alcohol and drug abuse, or other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, which are easy to cause loss of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning stiffness time;CCP;Patients' self-evaluation of the current overall condition of the disease;TCM syndrome score;DAS28 disease activity score;Evaluation of patient pain (rest pain);Doctor's evaluation of joint pain;ESR;Rheumatoid factor typing;Patient reported clinical outcome scale score;HAQ;Joint swelling number;Number of joint tenderness;CRP;Doctor's score of the patient's overall disease status; | — |
Countries
China
Contacts
Public ContactYanlin Chen
Outcome results
None listed