Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia
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
Beijing Zhecheng Biotechnology Co., Ltd.
196 participants
Jun 4, 2026
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria17
- Known allergy to any of the study medications, food products, or their components; current allergies; or known hypersensitivity;
- Active liver disease or cirrhosis, or liver dysfunction with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal (ULN);
- Acute infection or active gastrointestinal ulcers;
- History of thyroid dysfunction;
- Estimated glomerular filtration rate (eGFR) <60 mL/min;
- Severe cardiac diseases, such as decompensated heart failure (NYHA class III or IV), unstable angina, or a history of myocardial infarction within the previous 12 months;
- Renal cysts, medullary sponge kidney, or other obstructive nephropathies;
- Rheumatoid arthritis requiring treatment or arthropathies due to other causes;
- Current use of medications that affect urate levels, including febuxostat, allopurinol, benzbromarone, probenecid, azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, pyrazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (>325 mg/day) or other salicylates, losartan, or intravenous colchicine;
- Secondary hyperuricemia due to hematologic disorders, renal diseases, or radiotherapy/chemotherapy for malignancies;
- Brain disorders with impaired judgment, or mental disorders that preclude cooperation;
- Alcohol or substance abuse;
- Participation in another clinical trial within the three months prior to screening;
- Malignancy or active tuberculosis;
- Presence of other concurrent conditions that, in the investigator's judgment, may affect the efficacy evaluation or result in poor compliance;
- Use of glucocorticoids;
- Any other reason that, in the investigator's judgment, makes the participant unsuitable for enrollment in this trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Each effervescent tablet contains tart cherry extract and citrate. Participants take 4.0 g (one tablet) dissolved in 200-250 mL of water twice daily (morning and evening), regardless of meals. Daily total water intake is controlled at 2000-2500 mL. The tablet is taken as an adjunct to lifestyle guidance.
Matching placebo effervescent tablet identical in appearance, taste, and preparation to the tart cherry citrate effervescent tablet but containing no active ingredients. Participants take 4.0 g (one tablet) dissolved in 200-250 mL of water twice daily (morning and evening), regardless of meals. Daily total water intake is controlled at 2000-2500 mL. The tablet is taken as an adjunct to lifestyle guidance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07613138