ITMCTR2100005405招募中1 期
Clinical observation of modified Qianyang Fengsui pill in the treatment of mixed cold and heat syndrome of rheumatoid arthritis
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) 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.
排除标准
- •(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.
研究者
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