ITMCTR2100005379招募中1 期
Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria of Western medicine for rheumatoid arthritis; (2) RA patients who meet the diagnostic criteria of TCM syndrome of damp heat and blood stasis syndrome; (3) Meet the criteria of rheumatoid arthritis disease activity (5.1 > DAS28 score = 2.6); (4) Aged between 18 and 70 (regardless of gender and including 18 and 70); (5) It meets the standard classification of rheumatoid arthritis joint function (within the range of grade I - III); (6) The patient had not used biological agents within 30 days before entering the clinical study; For patients treated with glucocorticoids, the oral dose should be stable for at least 1 month and = 10mg before entering the clinical study; (7) The patient knows and voluntarily participates in the clinical study, agrees to sign the informed consent to enter the clinical study, and can actively cooperate with the doctor in treatment, observation and follow-up. Note: according to the above criteria, the patient can be excluded if one item cannot be met.
排除标准
- •(1) Does not meet the RA western medicine diagnosis and disease activity standards; (2) Those who do not accord with TCM syndrome differentiation and are RA damp heat and blood stasis syndrome; (3) The age range of patients is below 18 years old or over 70 years old, and women are in pregnancy, lactation or pregnancy preparation; (4) The patient's condition is in an advanced stage, the joint function grade is grade IV, the DAS28 score is = 2.6, there are serious deformity symptoms, weak physique, or allergic to the drugs involved in the study protocol and taboos, and the drug treatment effect is difficult to evaluate; (5) In addition to RA, patients have other autoimmune diseases, such as severe osteoarthritis, systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis / dermatomyositis, psoriatic arthritis, ankylosing spondylitis and other connective tissue diseases; (6) combined with severe pulmonary interstitial changes, severe liver and kidney dysfunction, cirrhosis, tuberculosis, malignant tumor, heart failure, cardiovascular, cerebrovascular, digestive, respiratory and hematopoietic system and other serious primary diseases. Psychotic patients (difficult to communicate in clinical research, even unable to take normal medication); Or suffering from infectious diseases (such as AIDS, tuberculosis, viral hepatitis, etc.); (7) Previous history of bleeding from skin, mucous membrane, digestive tract and internal organs, coagulation dysfunction diseases (such as hypercoagulable state, thrombocytopenic purpura, etc.), anemia (moderate, severe and extremely severe); (8) Those who need immunosuppressants according to the degree of disease development; Or the patient is using biological agents other than methotrexate; (9) 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; (10) The patient's compliance is poor, unable to cooperate with the doctor in this study, unable to take timely and quantitative medication according to the doctor's advice, and the clinical case data are incomplete; Patients who are within 30 days or are participating in clinical trials of other drugs; (11) There are any patients who are not suitable for inclusion in the clinical study. Note: if the patient has any of the above criteria, it can be excluded.
研究者
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