An interventional study of tart cherry citrate effervescent table and Placebo Control Group in Hyperuricemia With or Without Gout, sponsored by Beijing Zhecheng Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Beijing Zhecheng Biotechnology Co., Ltd. · Not applicable, Interventional, and Treatment
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:
The study will last 24 weeks.
Participants will:
Background and Rationale Hyperuricemia, a common metabolic disorder characterized by elevated serum urate due to purine metabolism dysfunction, affects 14.0% of Chinese adults (24.5% in men, 3.6% in women). Elevated serum urate leads to crystal deposition in joints, soft tissues, and kidneys, contributing not only to gout flares but also to renal and other organ damage. Although urate-lowering therapies (e.g., febuxostat, benzbromarone) effectively control serum urate, current guidelines do not recommend early pharmacological intervention for asymptomatic hyperuricemia due to safety concerns. Thus, additional strategies beyond lifestyle guidance are needed for this population.
Prior Research A prospective randomized study by the Affiliated Hospital of Qingdao University in 182 gout patients showed that a citrate mixture had comparable urate-lowering and urine alkalinization effects to sodium bicarbonate. After 3 months, the citrate effervescent tablet was superior in reducing hematuria and gout recurrence. Tart cherries, rich in anti-inflammatory and antioxidant anthocyanins, have been shown overseas to improve cardiovascular risk factors (blood pressure, cholesterol, blood glucose). The tart cherry citrate effervescent tablet enhances the original citrate mixture with increased citric acid and added tart cherry components.
A 24-week randomized, open-label, parallel-controlled trial in 282 male gout patients (fasting urine pH ≤6) demonstrated that the tart cherry citrate effervescent tablet had similar efficacy and safety to citrate mixture and sodium bicarbonate for urine alkalinization and serum urate lowering. However, it produced greater improvements in urinary albumin-to-creatinine ratio (UACR) and C-reactive protein (CRP), significantly reduced gout flare frequency, and improved metabolic parameters (systolic/diastolic blood pressure, fasting glucose, homeostasis model assessment-insulin resistance [HOMA-IR], total cholesterol).
Study Objectives To evaluate the efficacy and safety of tart cherry citrate effervescent tablet in participants with asymptomatic hyperuricemia.
Trial Design
Treatment Regimen
Details are provided in the study protocol.
Study Duration 24 weeks.
Outcome Measures
Efficacy outcomes:
Safety outcomes:
Efficacy Evaluation
Primary outcome:
-Difference in serum urate (sUA) levels between groups at week 24.
Secondary outcomes:
Safety Evaluation Monitoring of vital signs at each visit Clinically significant changes in safety laboratory parameters Documentation and assessment of all adverse events
Conclusion This randomized, placebo-controlled trial will compare the effects of tart cherry citrate effervescent tablet versus placebo plus lifestyle guidance on serum urate reduction in participants with asymptomatic hyperuricemia. The findings will provide new clinical data to support early intervention strategies for this condition.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 196 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →This is the only study on the registry with Beijing Zhecheng Biotechnology Co., Ltd. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lifestyle guidance + tart cherry citrate effervescent tablet 4.0 g twice daily
Dietary Supplement: tart cherry citrate effervescent table
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.
Dietary Supplement: Placebo Control Group
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.
Difference in serum urate (sUA) levels between groups at week 24
Serum uric acid measured in μmol/L from fasting blood sample.
Time frame: At week 24
Difference in serum urate (sUA) levels between groups at each visit
Time frame: At week 12 and week 24
Changes in serum urate (sUA) levels within the experimental group before and after intervention
Within-group change in sUA from enrollment to end of treatment.
Time frame: Baseline to Week 24
Difference in morning urine pH between groups at week 24
Time frame: At week 24
Differences in urine pH (morning urine) between groups at each visit
Time frame: At baseline, week 12, and week 24
Changes in 24-hour urinary uric acid excretion (UUE) within groups before and after intervention
Time frame: At baseline and week 24
Difference in estimated Glomerular Filtration Rate (eGFR) between groups at week 24
Time frame: At week 24
Change from baseline in eGFR at each visit
Time frame: At baseline, week 12, and week 24
Change from baseline in eGFR within the experimental group at week 24
Time frame: At baseline and week 24
Change from baseline in fasting blood glucose (FBG) between groups at week 12 and week 24
Time frame: At baseline, week 12, and the final visit
Change from baseline in systolic blood pressure (SBP) between groups at week 12 and week 24
Time frame: Baseline, week 12, week 24
Change from baseline in diastolic blood pressure (DBP) between groups at week 12 and week 24
Time frame: Baseline, week 12, week 24
Change from Baseline in Serum Total Cholesterol Concentration between Groups at Week 12 and Week 24
Time frame: Baseline, week 12, week 24
Change from Baseline in Serum Triglyceride Concentration between Groups at Week 12 and Week 24
Time frame: Baseline, week 12, week 24
Change from Baseline in Serum HDL Cholesterol Concentration between Groups at Week 12 and Week 24
Time frame: Baseline, week 12, week 24
Change from Baseline in Serum LDL Cholesterol Concentration between Groups at Week 12 and Week 24
Time frame: Baseline, week 12, week 24
Change from Baseline in Fasting Blood Glucose Concentration in the Experimental Group at Week 24
Time frame: At baseline and week 24
Change from baseline in systolic blood pressure (SBP) within the experimental group at week 24
Time frame: At baseline and week 24
Change from baseline in diastolic blood pressure (DBP) within the experimental group at week 24
Time frame: At baseline and week 24
Change from Baseline in Serum Total Cholesterol Concentration in the Experimental Group at Week 24
Time frame: At baseline and week 24
Change from Baseline in Serum Triglyceride Concentration in the Experimental Group at Week 24
Time frame: At baseline and week 24
Change from Baseline in Serum HDL Cholesterol Concentration in the Experimental Group at Week 24
Time frame: At baseline and week 24
Change from Baseline in Serum LDL Cholesterol Concentration in the Experimental Group at Week 24
Time frame: At baseline and week 24
Number of participants with new-onset gout flares
Time frame: From baseline to week 24
Number of participants with new-onset kidney stones
Time frame: From baseline to week 24
Change from baseline in kidney stone size (mm) within the experimental group
Time frame: Baseline and week 24
Changes in urate crystal volume (mm³) within groups before and after intervention
Time frame: Baseline and week 24
Plan to share: No — Individual participant data will not be shared because the informed consent form did not include provisions for data sharing beyond the primary study objectives, and the sponsor does not have an established data sharing platform.
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