Efficacy and safety of Qinpi Tongfeng Formula in the treatment of acute gouty arthritis: a randomized, double-blinded, double dummy, parallel-controlled trial

First Teaching Hospital of Tianjin University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Meet the diagnostic criteria of Western medicine for acute gouty arthritis;
•2. Meet the diagnostic criteria of damp heat accumulation syndrome of gout in traditional Chinese medicine;
•3. The patient's disease is within 72 hours of the onset of acute gouty arthritis;
•4. The patient has had gout at least once;
•5. The patient also needs to have moderate, severe or extreme joint pain, and the pain VAS score is >= 4;
•6. Those who did not take other drugs for gouty arthritis within 72 hours before enrollment;
•7. Those who have not taken uric acid lowering drugs in recent 2 weeks;
•8. Aged 18 to 70 years;
•9. The subjects agreed to join the study and signed the informed consent form.

•1. Secondary gouty arthritis caused by renal failure, tumor chemotherapy or radiotherapy, drugs, etc;
•2. Patients with chronic gout;
•3. Patients with inflammatory arthritis diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and knee osteoarthritis;
•4. The patient has multi joint gout (> 4 joints);
•5. Patients with serious primary diseases such as cardiovascular, cerebrovascular, lung, kidney, endocrine and hematopoietic system;
•6. Alt, AST or Cr are greater than 1.5 times ULN (upper limit of normal value);
•7. Those who are allergic to the test drug components;
•8. Patients with asthma, urticaria or allergic reaction induced by aspirin or other non steroidal anti-inflammatory drugs;
•9. Pregnant, pregnant or lactating women;
•10. Patients with active peptic ulcer or bleeding, or who have suffered from peptic ulcer or bleeding in the past;
•11. Those who have participated or are participating in other clinical trials in recent 1 month;
•12. Mental illness, lack of insight, unable to express accurately or take medicine on time, and unable to cooperate to complete the test.

发起方

First Teaching Hospital of Tianjin University of TCM