gout
Conditions
Interventions
citrate effervescent tablets(FengLing) group:Febuxostat 20mg qd + citrate effervescent tablets 3.5g bid (initial treatment)
Febuxostat 40mg qd + citrate effervescent tablets 3.5g bid (adjusted based on urate level)
sodium bicarbonate group:Febuxostat 20mg qd + sodium bicarbonate 1g tid (initial treatment)
Febuxostat 40mg qd + sodium bicarbonate 1g tid (adjusted based on urate level)
tart cherry citrate effervescent tablets(FengLing+) group:Febuxostat 20mg qd + tart cherrycitrate effervescent tablets 3.5g bid (initial treatment)
Febuxostat 40mg qd + tart cherry citrate effervescent tablets 3.5g bid (adjusted based on urate level)
Sponsors
Affiliated Hospital of Qiingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men aged 18-70 years; 2. After 2 weeks of washout, conform to the diagnostic criteria of primary gout, 7.0 mg/dL (420 micromol/L) < serum uric acid < 10.1 mg/dL (600 umol/L); 3. Patients with morning urine pH <= 6.0; 4. The patients who did not attack acute gouty arthritis in the first 2 weeks and the elution period were selected; 5. Patients who voluntarily participate in and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to all drugs, foods or their components in this test, or those who have existing allergies, or those who have hypersensitivity constitution; 2. Patients with active liver disease or liver cirrhosis, or with abnormal liver function, with serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceeding 2 times the upper limit of the normal range; 3. Patients with active peptic ulcer; 4. Thyroid dysfunction; 5. Glomerular filtration rate < 60ml/min; 6. Patients with severe heart disease, such as: decompensated heart failure (NYHA stage III and IV); unstable angina pectoris; history of myocardial infarction within the past 12 months, etc.; 7. Patients with kidney stones, renal cysts, sponge kidney or other obstructive nephropathy; 8. Patients with xanthineuria; 9. Rheumatoid arthritis and joint diseases caused by other reasons that need to be treated; 10. Currently using azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, pyrazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325mg/ Day) or other salicylic acid drugs, losartan, intravenous colchicine treatment; 11. Patients with secondary hyperuricemia caused by blood disease, kidney disease or tumor radiotherapy and chemotherapy; 12. Brain disease, abnormal judgment ability; mental illness unable to cooperate; 13. Alcohol or drug addicts; 14. Those who have participated in other clinical trials within three months before the screening of this trial; 15. Malignant tumor, active tuberculosis; 16. Complicated with other diseases, and the researchers believe that it will affect the evaluation of efficacy or poor compliance; 17. Those taking glucocorticoid drugs; 18. White blood cell count < 4.0x10^9/L, or platelets < 100x10^9/L, or hemoglobin < 90g/L; 19. For any other reason, the investigator thinks it is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum uric acid;Urinary pH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;Blood biochemistry;Erythrocyte sedimentation rate;C reactive protein;Glycoprotein antigen 72-4;Urine routine;Urine biochemistry;Urine microalbumin/creatinine;Hepatobiliary, Pancreas, Spleen and Kidney Ultrasound;Joint ultrasound;Cystatin C;Dual-energy computed tomography;The frequency of acute gout; | — |
Countries
China
Contacts
Public ContactLi Changgui
Qingdao University
Outcome results
None listed