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RECRUITING
NCT06966635
PHASE4

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

312

Start Date

2024-04-10

Completion Date

2026-04-30

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

Huashan hospital, Fudan university

Shanghai, China