ITMCTR2100004311招募中1 期
A multicenter, randomized, double-blind, parallel controlled clinical trial on the efficacy and safety of Chuanhu Qutong Granules in the treatment of acute gouty arthritis
Affiliated Hospital of Qingdao University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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 75（—）
- 性别
- All
入选标准
- •(1) Meets the 2015 ACR/EULAR classification and diagnostic criteria for gout;
- •(2) In line with the diagnostic criteria of rheumatism and heat stagnation for gout in the Standards for Diagnosis and Efficacy of Diseases and Syndromes of Traditional Chinese Medicine issued by the State Administration of Traditional Chinese Medicine in 2017;
- •(3) The course of the attack was within 48 hours when randomly enrolled;Patients who have not used any therapeutic drugs (including colchicine, non-steroidal anti-inflammatory drugs and hormones) during this episode;
- •(4) Aged between 18 and 75 years, gender is not limited.
- •(5) Patients who signed the informed consent to take the medication as required by the study protocol and were evaluated.
排除标准
- •(1) Secondary gout, joint lesions caused by other diseases (such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, silver-dural arthritis, pseudogout, lupus erythematosus, etc.);Chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive kidney disease and other joint lesions;
- •(2) Patients with advanced deformity, disability, loss of working ability, and cardiovascular and cerebrovascular diseases induced by pain;
- •(3) Have severe cardiovascular disease, liver disease, renal disease, hematologic disease, lung disease, or other serious disease affecting their survival, such as tumor or AIDS;
- •(4) ALT > 2 times the upper limit of normal; CR > upper limit of normal value; Urinary protein >+; Arrhythmias of clinical significance.
- •(5) Are taking drugs for blood uric acid metabolism, such as dihydroclorazide, furosemide, diuric acid, pyrazinamide, low-dose aspirin, etc., as well as drugs containing the above-mentioned ingredients, such as compound antihypertensive tablets;Or had taken glucocorticoids within 1 month before enrollment; Or use of nonsteroidal anti-inflammatory drugs or other pain medications within 48 hours prior to baseline evaluation;
- •(6) Women who are pregnant, lactating or have a recent birth plan;
- •(7) Patients with active gastrointestinal ulcer or taking anti-ulcer drugs;
- •(8) People with mental or legal disabilities
- •(9) Suspected or confirmed history of alcohol or drug abuse, or other diseases that, according to the investigator's judgment, reduce the possibility of inclusion or complicate inclusion, such as frequent changes in the work environment, which may easily cause loss of follow-up;
- •(10) People who are known to be allergic to the components of this drug;
- •(11) Those who have participated in or are participating in clinical trials within the last 3 months.
研究者
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