A Phase 4 interventional study of Sodium Bicarbonate Oral Capsule and Potassium Citrate Tablets in Hyperuricemia or Gout and Nephrolithiasis, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Huashan Hospital · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: uric-acid-lowering drug
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time.
Drug: Potassium Citrate Tablets · Drug: uric-acid-lowering drug
Sodium Bicarbonate Oral Capsule
Drug: Sodium Bicarbonate Oral Capsule · Drug: uric-acid-lowering drug
On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time
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. The treatment plan for lowering uric acid remained unchanged for 4 weeks after enrollment in the clinical study until the endpoint.
serum uric acid
Time frame: From enrollment to the end of treatment at 48 weeks
gout flare
Time frame: From enrollment to the end of treatment at 48 weeks
nephrolithiasis
Time frame: From enrollment to the end of treatment at 48 weeks
Plan to share: Yes — all IPD collected throughout the trial. Contact the author by email after the research is completed.
Supporting information: Study protocol, Sap, Icf, Csr
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Huashan Hospital