A double-blind randomized controlled trial of Qizhi Tongfeng Granule in the treatment of chronic refractory gout
- Conditions
- Gout
- Registration Number
- ITMCTR2200006076
- Lead Sponsor
- Fangshan Hospital Affiliated to Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Voluntarily participate in the clinical study and sign the informed consent;
(2) It conforms to the diagnostic criteria of refractory chronic gout set by The Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout in 2019;
(3) Conforming to the criteria for waiting diagnosis of spleen deficiency, turbidity and stasis;
(4) No acute attack within 4 weeks;
(5) Between 18 and 75 years of age, regardless of gender
(1) Secondary gout: gout caused by renal failure, diuretics, pyrazinamide, etc.;
(2) Having an allergic constitution and being known or suspected to be allergic to the test drug and its excipients;
(3) complicated or secondary chronic kidney disease (such as uric acid nephropathy);
(4) complicated with serious cardiovascular and cerebrovascular diseases, primary diseases of blood, liver and kidney system, or complicated with mental diseases;
(5) complicated with acute infectious diseases, active or delayed chronic hepatitis B, decompensated cirrhosis, active tuberculosis;
(6) Unstable vital signs, severe electrolyte disorder, or renal replacement therapy has been performed;
(7) Long-term use of other Traditional Chinese medicine preparations for more than 4 weeks with other diseases;
(8) pregnant women, breast-feeding women or women with recent pregnancy plans;
(9) Have participated in or are participating in other clinical trials within the last 3 months;
(10) The investigator considers it inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood uric acid;Tophi;
- Secondary Outcome Measures
Name Time Method umber of tenderness joints;Pain score;Synovitis;Serum xanthine oxidase;Frequency of acute attacks of gouty arthritis;Evaluation of TCM syndrome effect;Number of swollen joints;Serum interleukin-1ß;Serum tumor necrosis factor -a;Serum interleukin-6;