Tart Cherry Citrate Tablet for Lowering Urate in Asymptomatic Hyperuricemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, parallel-group trial, adults with asymptomatic hyperuricemia will receive either tart cherry citrate effervescent tablets or a matching placebo for 24 weeks, in addition to lifestyle guidance. Both groups will have regular clinic visits and tests to monitor uric acid and safety. The goal is to see if the cherry citrate formulation reduces serum urate more effectively than placebo when combined with lifestyle changes. The study is open-label with a parallel control and focuses on understanding the potential urate-lowering effect and safety in this population. The lead sponsor is Beijing Zhecheng Biotechnology, with recruitment at Xiamen University Xiang'an Hospital in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xiamen University Affiliated Xiang'an Hospital
  Xiamen, Fujian, China Recruiting

Study contacts

• Study coordinator: Rui Wang, PhD
• Email: wangrui@zcbiometech.com
• Phone: 86 010 64935208

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.