Gout
Conditions
Interventions
Intervention group:Febuxostat tablet 40mg once a day + Qizhi Gout granules, 1 dose a day, divided into 2 times, orally.
Control group:Febuxostat tablet 40mg once a day + Qizhi gout granule placebo, 1 dose, 2 times a day, orally.
Sponsors
Fangshan Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood uric acid;Tophi; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number 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; | — |
Countries
China
Contacts
Public ContactSun luying
Outcome results
None listed