NCT06966635

Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

• Hyperuricemia or Gout
• Nephrolithiasis

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate Oral Capsule	On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time
DRUG	Potassium Citrate Tablets	On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time
DRUG	uric-acid-lowering drug	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.

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: China