Rheumatoid Arthritis
Conditions
Interventions
observation group:Coix seed granules combined with western medicine basic treatment
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 to 75 years old (inclusive) regardless of gender; (2) Meet the diagnostic criteria of Western medicine for rheumatoid arthritis at the time of screening that is meet the 2010 American Society of Rheumatology (ACR)/European Alliance Against Rheumatology (EULAR) RA classification criteria; (3) Meet the TCM diagnostic criteria for phlegm syndrome at the time of screening; (4) At the time of screening the patient meets the following conditions: A. Rheumatoid arthritis is in active disease: 1) Joints with at least three or more painful swelling;2)2.62.8;3) Meet at least one of the three conditions: erythrocyte sedimentation rate (ESR) is higher than the upper limit of normal or C-reactive protein (CRP) is higher than the upper limit of normal or morning stiffness>1 hour. B.ACR functional classification is Class I-III; (5) Currently using or doctors consider it appropriate to use at least one anti-rheumatic drug including traditional disease-modifying anti-rheumatic drugs (DMARDs) non-steroidal anti-inflammatory drugs oral glucocorticoids etc. and maintain a stable dose for>4 weeks; (6) Those who have not participated in any clinical trial within 4 weeks prior to inclusion; (7) Agree not to participate in other studies and will not receive other rheumatoid arthritis treatments and immunomodulators treatment while participating in this study; (8) Men or women who do not have childbearing requirements; (9) Understand and sign the informed consent form before performing any steps related to this study and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: (1) Those who have previously received treatment with targeted small molecule drugs and biologics including tumor necrosis factor (TNF) a-antagonists (such as etanercept infliximab and adalimumab) interleukin (IL)-1 and IL-6 antagonists and have stopped the drug for less than 4 weeks; (2) Those who have previously received antirheumatic drugs immunosuppressants hormones etc. other than the drugs specified in the trial and have stopped taking the drug for less than 4 weeks; (3) Those who have received traditional Chinese medicine decoction or proprietary Chinese medicine within 4 weeks before enrollment; (4) Women who are pregnant nursing and have plans to get pregnant during treatment and/or within 12 weeks after treatment; (5) Patients with severe diseases associated with important organs such as cardiovascular brain liver lung kidney and hematopoietic system acute and chronic infectious diseases malignant tumors and mental diseases; (6) Patients with white blood cell count <3.0×10^9/L or hemoglobin <90 g/L or blood platelet count <100.0×10^9/L; patients with active liver disease or abnormal liver function with AST and ALT higher than the upper limit of normal; patients with abnormal renal function with creatinine (Cr) higher than the upper limit of normal; (7) Autoimmune diseases other than RA including but not limited to Sjogren's syndrome psoriatic arthritis ankylosing spondylitis systemic lupus erythematosus mixed connective tissue disease scleroderma etc. or any active inflammatory patient; (8) Hypersensitivity to or allergic to experimental drugs (including basic drugs emergency drugs and any known ingredients of Coix seed); (9) Those who are participating in other trials or who have participated in clinical trials of other drugs within 3 months; (10) Persons with a history of alcohol or drug abuse; (11) There are circumstances where other investigators believe that they cannot participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Classification of joint function in rheumatoid arthritis;ppar ?;NRS-2002;C-Reactive Protein;VAS;phlegm syndrome score;IL-10;HAQ-DI;Erythrocyte Sedimentation Rate;CDAI;leptin;Simplified joint ultrasound scoring;IL-17;Morning stiffness score;muscle mass and function; | — |
Countries
China
Contacts
Public ContactZhang Jie
The First Affiliated Hospital of China Medical University
Outcome results
None listed