Efficacy and safety of Qinpi Tongfeng Formula in the treatment of acute gouty arthritis: a randomized, double-blinded, double dummy, parallel-controlled trial
- Conditions
- Acute gouty arthritis
- Registration Number
- ITMCTR2100005258
- Lead Sponsor
- First Teaching Hospital of Tianjin University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain score;
- Secondary Outcome Measures
Name Time Method erythrocyte sedimentation rate;Traditional Chinese Medicine syndrome score;Joint symptom score;blood uric acid;Patient satisfaction score;Complete pain relief time;Total effective rate;C-reactive protein;