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Effects of urine alkalization in gout patients: a prospective, randomized controlled trial

Effects of urine alkalization in gout patients: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032908
Enrollment
Unknown
Registered
2020-05-15
Start date
2020-05-20
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

Sodium bicarbonate group:Urine alkalization control drugs sodium bicarbonate were taken for one month at a dose of 3 × 1.0 g/day,at the same time, the uric acid-lowering drug febuxostat tablets was t
Sodium hydrogen citrate group:Urine alkalization control drugs sodium hydrogen citrate were taken for one month at a dose of 3 × 2.5 g/day,at the same time, the uric acid-lowering drug febuxostat tabl

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patients aged 18 to 80 years, male, meet the clinical classification and diagnosis criteria of gout of 2015 ACR / eluar; 2. Patients with serum uric acid value >=360 umol/L; 3. Patients with urine pH < 6.0; 4. Obtain the consent of the subject, or family member, or guardian, or legal representative and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic or contraindicated to all drugs or ingredients in the test, or those who are allergic to or have high sensitivity constitution; 2. The patients who had acute gouty arthritis attack in the first two weeks of randomization; 3. Patients who used antiduricemic drugs within 2 weeks before randomization; Four Glucocorticoids, antituberculosis drugs (such as ethambutol, pyrazinamide), anticoagulants (such as warfarin or other coumarin anticoagulants, bivalirudin), immunosuppressants (such as cyclosporin, tacrolimus), aspirin or other salicylic acid substances, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfamethoxate, etc. were used or planned to be used within the first two weeks of randomization Oxazole, trimethoprim, theophylline, niacin, estrogen and other drugs that affect the metabolism of uric acid; 5. Patients with active peptic ulcer, abnormal thyroid function, malignant tumor, active tuberculosis and urinary calculi; 6. Patients with rheumatoid arthritis, rheumatoid arthritis, arthritis caused by other rheumatic immune diseases, or osteoarthritis requiring analgesic treatment; 7. Patients with heart failure with limited activity (previously confirmed, or with clinical manifestations of heart failure, confirmed after consultation with cardiology department), unstable angina pectoris, previous history of myocardial infarction within 12 months or other patients with serious heart disease; 8. Patients with secondary hyperuricemia caused by hematopathy, malignant tumor, kidney disease or tumor radiotherapy and chemotherapy; 9. In patients with renal insufficiency; 10. Patients with active liver disease or cirrhosis, or abnormal liver function [patients with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=1.5 ULN or TBIL >=1.5 ULN; 11. Patients with severe hypertension (systolic blood pressure > 160mmhg or diastolic blood pressure > 100mmhg) who were not effectively controlled after treatment; 12. Patients who are receiving or do not receive hypoglycemic drugs but HbA1c > 8%; 13. Leukocyte count < 3.5x10^9/L, platelet <100x10^9/L, hemoglobin <90g/L; 14. Patients with brain diseases, abnormal judgment ability and uncooperative mental disorders; 15. Patients who have a history of drinking or taking illegal drugs; 16. Patients who have participated in other clinical trials within three months before the screening of this trial; 17. Patients considered unsuitable by other researchers.

Design outcomes

Primary

MeasureTime frame
Urinary pH;

Secondary

MeasureTime frame
Serum uric acid;Urinary uric acid;Urinary creatinine;Fatty liver;Kidney stones;Tophus;Systolic blood pressure;Diastolic blood pressure;Height;Weight;Alanine aminotransferase;Aspartate aminotransferase;Total cholesterol;Triglycerides;Fasting plasma glucose;Urea nitrogen;Serum creatinine;

Countries

China

Contacts

Public ContactChanggui Li

Affiliated Hospital of Qingdao University

lichanggui@medmail.com.cn+86 532-82912017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026