💬In plain words
What the trial is, and whether it could suit you
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 lifesty
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Aged 18 to 65 years, regardless of sex;
2. 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);
3. Participants with asymptomatic hyperuricemia who have not previously received urate-lowering therapy and have no history of acute gout flares;
4. Voluntarily participate in the study and provide written informed consent.
Exclusion Criteria:
1. Known allergy to any of the study medications, food products, or their components; current allergies; or known hypersensitivity;
2. 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);
3. Acute infection or active gastrointestinal ulcers;
4. History of thyroid dysfunction;
5. Estimated glomerular filtration rate (eGFR) \<60 mL/min;
6. 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;
7. Renal cysts, medullary sponge kidney, or other obstructive nephropathies;
8. Rheumatoid arthritis requiring treatment or arthropathies due to other causes;
9. 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;
10. Secondary hyperuricemia due to hematologic disorders, renal diseases, or radiotherapy/chemotherapy for malignancies;
11. Brain disorders with impaired judgment, or mental disorders that preclude cooperation;
12. Alcohol or substance abuse;
13. Participation in another clinical trial within the three months prior to screening;
14. Malignancy or active tuberculosis;
15. Presence of other concurrent conditions that, in the investigator's judgment, may affect the efficacy evaluation or result in poor compliance;
16. Use of glucocorticoids;
17. Any other reason that, in the investigator's judgment, makes the participant unsuitable for enrollment in this trial.
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