gout
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 75 years old male or female; 2) According to the diagnostic criteria for primary gout (2015 ACR/EULAR standard), 420µmol/L sputum uric acid =540µmol/L; 3) triglyceride =2.3mmol/L or triglyceride = 1.92mmol/L after strict diet control; 4) Voluntarily participate in and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to the medication or ingredients in this test, are contraindicated, or have allergies to the disease, high-sensitivity constitution; 2) The author of acute gouty arthritis within 2 weeks prior to randomization; 3) Use uric acid lowering drugs within 2 weeks before randomization; 4) Use or plan to use glucocorticoids, anti-tuberculosis drugs (such as ethambutol, pyrazinamide), anticoagulants (such as warfarin or other coumarins) after randomization within 2 weeks prior to randomization Agent, bivalirudin), immunosuppressant (eg cyclosporin, tacrolimus), aspirin or other salicylic acid, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfamethoxazole , trimethoprim, theophylline, niacin, estrogen and other drugs that affect uric acid metabolism; 5) patients with active peptic ulcer, thyroid dysfunction, malignant tumor, active tuberculosis, and urinary calculi; 6) Arthritis caused by rheumatoid arthritis, rheumatoid arthritis, other rheumatic immune diseases, or osteoarthritis requiring analgesics; 7) Heart failure with limited mobility (previous diagnosis, clinical manifestations of heart failure, diagnosis after cardiology consultation), unstable angina pectoris, history of myocardial infarction or other severe heart disease in the past 12 months; 8) Patients with secondary hyperuricemia caused by blood diseases, malignant tumors, kidney diseases or tumor radiotherapy and chemotherapy; 9) Patients with severe renal insufficiency (GFR 1.5 times ULN or TBIL = 1.5 times ULN]; 11) Patients with severe hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) who are not effectively controlled after treatment; 12) Patients who are receiving hypoglycemic drugs or who do not receive hypoglycemic drugs but have HbA1c > 8%; 13) White blood cell count <3.5 x 109 /L, or platelets <100 x 109 /L, or hemoglobin <90g/L; 14) Brain diseases, abnormal judgment ability, and mental illness cannot cooperate; 15) History of alcohol abuse or illicit drugs; 16) pregnant women, lactating women or preparing for pregnancy (including male subjects); 17) Those who have participated in other clinical trials within the first three months of screening; 18) Other investigators consider it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| fraction excretion of uric acid;Triglyceride;Urine PH;eGFR, Estimated Glomerular Filtration Rate;AST, ALT; | — |
Countries
China
Contacts
Affiliated Hospital of Qingdao University