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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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, gender is not limited

• The interval between the most recent acute onset of gout is at least \> 2 weeks

• Routine treatment with stable dose of uric-lowering drugs for \> 4 weeks

• For women who are likely to become pregnant, pregnancy tests must be negative, they must not be lactating, they must be using an investigator-approved method of contraception, and they must agree to maintain this method of contraception throughout the study

• Study participants were informed, voluntarily signed informed consent, and agreed to participate in all visits, examinations, and treatments as required by the trial protocol

• Informed consent to the purpose and content of the research.

Locations
Other Locations
China
Huashan hospital, Fudan university
RECRUITING
Shanghai
Contact Information
Primary
Yu Miao
my20000109@126.com
021-17857540080
Time Frame
Start Date: 2024-04-10
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 312
Treatments
Active_comparator: Controll group
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.
Experimental: Potassium citrate group
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time.
Experimental: Sodium bicarbonate group
Sodium Bicarbonate Oral Capsule
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov