ITMCTR2000003933招募中4 期
A randomized, controlled, single center clinical trial of total glucosides of paeony in the prevention of gout
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Department of Rheumatology and Immunology0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 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 65（—）
- 性别
- Male
入选标准
- •1. The age of 18-65 years old patients with autonomic activity ability, male patients;
- •2. The patients who met the diagnostic criteria of gout (American Society of Rheumatology, 1977); the number of gouty arthritis episodes >= 1 in recent half a year;
- •3. Patients with serum uric acid level >= 8.0 mg / dl (480 µ mol / L);
- •4. The patients voluntarily participated in the trial and signed the informed consent.
排除标准
- •1. The patients with acute gouty arthritis within one month before enrollment; patients with acute gouty arthritis more than 6 times or single attack duration >= 2 weeks in one year before enrollment;
- •2. Patients with active liver disease or abnormal liver function (ALT and AST are 2 times or more of the upper limit of normal value), and patients with impaired renal function (CR value exceeding the upper limit of normal value);
- •3. Subjects with white blood cell < 4.0 x 10^9 / L, anemia (hemoglobin less than 100g / L), platelet < 100 x 10^9 / L, or other blood system diseases;
- •4. Patients with serious heart, lung, central nervous system disease or malignant tumor;
- •5. Patients with mental illness or mental retardation who can not correctly describe their own feelings or cannot take medicine according to the doctor's advice;
- •6. Patients with hypertension and diabetes mellitus;
- •7. Patients with chronic diffuse connective tissue disease;
- •8. Patients with active peptic ulcer history in recent one year;
- •9. Patients with history of alcoholism, drug abuse or drug abuse in recent one year;
- •10. Patients who need to use the prohibited drugs prescribed in the protocol during the trial period;
- •11. Patients with allergic constitution or allergic to research drugs;
- •12. Patients in the control group were randomly assigned to other drugs such as norbutamol or norbutamol within 4 weeks;
- •13. Patients who participated in clinical trials of other drugs within 30 days before screening.
- •14. In addition to the above criteria, the investigator or Assistant Investigator determined that the patient was not suitable for the study.
研究者
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