Actively Recruiting
Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets
Led by Huashan Hospital · Updated on 2025-05-13
312
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate whether alkalization has the effect of lowering uric acid and reducing gout flare and determine whether alkalization has a role in the prevention and treatment of urinary calculi in gout, the research participants were divided into the control group, the potassium citrate group and the sodium bicarbonate group. 2 alkalization groups took potassium citrate three times a day 2.16g each time, or sodium bicarbonate three times a day, 1.0g each time, on the basis of the standard uric acid-lowering treatment plan. The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable.
CONDITIONS
Official Title
Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria of the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) for gout in 2015
- Age 18-70 years old, any gender
- At least 2 weeks since the most recent acute gout attack
- Routine treatment with stable dose of uric acid-lowering drugs for more than 4 weeks
- For women who may become pregnant, negative pregnancy test, not breastfeeding, using approved contraception, and agree to maintain contraception during the study
- Informed consent signed voluntarily, agreeing to participate in all visits, exams, and treatments as required
- Understand and consent to the purpose and content of the research
You will not qualify if you...
- Acute gout flare
- Secondary gout caused by kidney disease, blood disease, certain drugs, tumor radiotherapy or chemotherapy
- Severe unstable cardiovascular or cerebrovascular diseases, acute uncontrolled diseases, chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhan syndrome, untreated thyroid disease or kidney stones
- Severe hypertension (blood pressure > 160/100 mmHg), uncontrolled diabetes (fasting glucose > 11.1 mmol/L), or organ transplantation not well controlled
- Allergy or history of allergy to study drugs or components (febuxostat, allopurinol, benzbromarone, etoricoxib, colchicine, potassium citrate, etc.)
- Active peptic ulcer with bleeding or perforation, severe chronic diarrhea, or recurrent skin disease within the past year
- Low white blood cell count (< 3.0x10^9/L), hemoglobin (< 90 g/L), platelet count (< 100x10^9/L), or other blood system diseases
- Active liver disease or abnormal liver function (ALT or AST ≥ 2 times upper limit of normal)
- Abnormal kidney function (eGFR ≤ 60 ml/min/1.73 m²)
- Elevated blood potassium (≥ 5.5 mmol/L) or conditions leading to hyperkalemia
- Urine pH value > 6.5 during screening
- Use of certain drugs including high-dose aspirin (> 300 mg/day), thiazide diuretics, potassium-sparing diuretics, ACE inhibitors, azathioprine, 6-mercaptopurine, theophylline, losartan, cyclosporin A, cyclophosphamide, pyrazinamide, glucocorticoids (except in acute episodes), Niergoline tablets, long-term insulin, or digitalis
- Pregnant, planning pregnancy, or breastfeeding
- Mental illness or inability to understand or comply with medication
- History of alcohol abuse or drug dependence within the last two years
- Participation in other clinical trials within the last three months
- Family member or relative of the research center staff
- Other conditions judged by the investigator to reduce or complicate enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huashan hospital, Fudan university
Shanghai, China
Actively Recruiting
Research Team
Y
Yu Miao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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