Clinical Research Directory

Inclusion Criteria: * Male or female individuals aged 18-70 years old. * Meet the 2015 ACR/EULAR diagnostic criteria of gout. * With an onset of acute gout flares within 7 days. * With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol/L and/or has co-morbidities (renal function impairment, hypertension,). * Provide a signed written informed consent form. Exclusion Criteria: * Has secondary hyperuricemia. * Serum uric acid level \< 360 μmol/L. * Used IL-1β inhibitors within 6 months before screening. * Used uric acid-lowering drugs within 1 month before screening. * Used anti-inflammatory drugs within 14 days before screening. * Comorbidities with nephrolithiasis or clinical urinary calculi * History of kidney transplantation or dialysis. * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m². * AST or ALT \> 2 times the upper limit of normal. * Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period. * White blood cell count \< 3.5 × 10⁹/L, or platelet count \< 100 × 10⁹/L, or hemoglobin \< 90 g/L. * Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period. * Congestive heart failure (New York Heart Association \[NYHA\] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty). * Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations). * Have active gastrointestinal ulcers/bleeding, or have had a recurrence of ulcers/bleeding in the past.