gout
Conditions
Interventions
Control group:ULT + citric acid analog tablet
Experimental group:ULT+ citric acid mixture
Sponsors
Affiliated Hospital of Qiingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 -75 years, male; (2) Obtain the consent of the subject, his/her family member, guardian, or legal representative and sign the informed consent; (3) Met the clinical diagnostic criteria for gout (2015ACR/ELUAR diagnostic criteria), did not use uric acid-lowering drugs in the first 2 weeks, and the acute attack of gout was relieved for at least 2 weeks; (4) Serum uric acid value >= 420 mol/L (7 mg/dL); (5) Other concomitant diseases (such as hypertension, hyperlipidemia, diabetes, etc.) were stable, and the drug dose remained unchanged throughout the trial period. (6) eGFR >= 30 mL/min. (7) Urine pH < 6.0
Exclusion criteria
Exclusion criteria: If any one of the following criteria is met, it shall be excluded: (1) Allergic or contraindicated to all drugs or ingredients used in this study, or allergic or hypersensitive to current conditions; (2) Patients with acute gouty arthritis in the first 2 weeks were randomly selected; (3) Randomized use of uric acid-lowering drugs in the first 2 weeks; (4) random 2 weeks before use or plan after the random use of glucocorticoid, anti-tb drugs (e.g., ethambutol, pyrazinamide), anticoagulants such as warfarin or other coumarin anticoagulants, than cut Lu Ding), immunosuppressants (such as loop spore fungus element, tacrolimus), aspirin or other salicylic acid substances, azathioprine and 6-mercaptopurine, cyclophosphamide, sulfamethoxazole, methoxyl benzyl organism, theophylline, niacin, estrogen, the uric acid metabolism of drugs; (5) Patients with active gastrointestinal ulcer, abnormal thyroid function, malignant tumor, active tuberculosis, urinary calculi; (6) Rheumatoid arthritis, rheumatoid arthritis, arthritis caused by other rheumatic immune diseases, or osteoarthritis requiring the treatment of analgesics; (7) Patients with heart failure with limited activity (previously diagnosed, or with clinical manifestations of heart failure, diagnosed after consultation in the department of cardiology), unstable angina pectoris, history of myocardial infarction within 12 months or other severe heart disease; (8) Patients with secondary hyperuricemia caused by hematologic disease, malignant tumor, kidney disease or tumor chemoradiotherapy; (9) Patients with severe renal insufficiency (eGFR = 1.5 times ULN]; (11) Severe hypertension not effectively controlled after treatment (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) patients; (12) Receiving or not receiving hypoglycemic drug therapy but HbA1c > 8% of patients; (13) White blood cell count < 3.5 x 10^9/L, or platelet < 100 x 10^9/L, or hemoglobin < 90 g/L; (14) Inability to cooperate with others due to brain diseases, abnormal judgment and mental disorders; (15) A history of alcohol abuse or illegal drug use; (16) Pregnant women, lactating women or preparing for pregnancy (including male subjects); (17) Screening of patients who had participated in other clinical trials in the previous three months; (18) Subjects considered inappropriate by other researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine pH;eGFR;kidney stone;Renal cyst; new onset hematuresis;new on- seturine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum urate;fast glucose;TG;TC;CR;BUN;ALT;AST;blood pressure;gout flare frequency; | — |
Countries
China
Contacts
Public ContactLiChanggui
Affiliated Hospital of Qiingdao University
Outcome results
None listed