Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia: A Study Protocol for a Single-Center, Randomized, Placebo-Controlled Trial
The goal of this clinical trial is to learn whether tart cherry citrate effervescent tablets can lower uric acid levels in people with asymptomatic hyperuricemia (high uric acid levels without gout symptoms). The main question it aims to answer is: Does taking tart cherry citrate effervescent tablets lower uric acid levels more effectively than taking a placebo (inactive) tablet, when both groups also receive lifestyle guidance? Researchers will compare two groups of participants. Both groups will receive lifestyle guidance (advice on diet and exercise). In addition: * One group will take the tart cherry citrate effervescent tablets. * The other group will take a placebo effervescent tablet (looks and tastes the same but contains no active ingredient). The study will last 24 weeks. Participants will: * Take the assigned effervescent tablet twice daily for 24 weeks * Follow lifestyle guidance for diet and exercise * Attend scheduled clinic visits for checkups and tests * Provide blood and urine samples for testing
• Aged 18 to 65 years, regardless of sex;
• Meet the diagnostic criteria for primary hyperuricemia, with serum urate levels between 420 μmol/L and 540 μmol/L (for those without comorbidities) or between 420 μmol/L and 480 μmol/L (for those with at least one of the following comorbidities: hypertension, dyslipidemia, diabetes mellitus, obesity, stroke, coronary heart disease, heart failure, or CKD stage ≥2);
• Participants with asymptomatic hyperuricemia who have not previously received urate-lowering therapy and have no history of acute gout flares;
• Voluntarily participate in the study and provide written informed consent.