gout
Conditions
Interventions
Group 1:Benzbromarone 25 mg qd + purified water 1860 ml
Group 2:Benzbromarone 25mg qd + Taiji water 1860ml
Group 3:Benzbromarone 25mg qd + soda water 1860 ml
Sponsors
Affiliated Hospital of Qiingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years male, meets the 2015 ACR/ELUAR clinical classification of gout diagnostic criteria; (2) Serum uric acid value= 420 micromol/L(7mg/dL); (3) Obtain the consent of the subject, family member, guardian or legal agent and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) allergies or contraindications to all medicines or their ingredients, or allergies or hypersensitive constitutions; (2) Those who had acute gouty arthritis in the first two weeks at random; (3) Use of hypouric acid drugs within the first two weeks at random; (4) Glucocorticoids, anti-tuberculosis drugs (e.g. ethambutol, pyrazinamide), anticoagulants (e.g. warfarin or other coumarin anticoagulants, bivalirudin), immunosuppressants (e.g. cyclosporine, tacrolimus), aspirin or other salicylic acid substances, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfur) were used or planned to be used within the first two weeks of randomization. Aminoxazole, trimethoprim, theophylline, nicotinic acid, estrogen and other drugs affecting uric acid metabolism; (5) Patients with active gastrointestinal ulcer, thyroid dysfunction, malignant tumors, active tuberculosis and urinary calculi; (6) Arthritis caused by rheumatoid arthritis, rheumatoid arthritis and other rheumatic immune diseases, or osteoarthritis requiring analgesic treatment; (7) Heart failure with limited activity (previously diagnosed, or clinical manifestations of heart failure, confirmed after consultation with cardiology department), unstable angina pectoris, past 12 months with a history of myocardial infarction or other serious heart disease patients; (8) Patients with secondary hyperuricemia caused by hematological diseases, malignant tumors, kidney diseases or tumor radiotherapy and chemotherapy; (9) For severe renal insufficiency (eGFR 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 were not effectively controlled after treatment; (12) Patients who are receiving hypoglycemic drugs or not receiving hypoglycemic drugs but with HbA1c > 8%; (13) Leukocyte count < 3.5 x 10^9/L, platelet < 100 x 10^9/L, or hemoglobin < 90 g/L; (14) Those with brain diseases, abnormal judgment and mental disorders who can not cooperate; (15) A history of alcohol abuse or illegal drug use; (16) Pregnant women, lactating women or pregnant women (including male subjects); (17) Those who had participated in other clinical trials within three months before screening in this trial; (18) Other researchers considered it inappropriate to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine PH;Serum uric acid;The size of gout stone or uric acid salt crystalline; | — |
Secondary
| Measure | Time frame |
|---|---|
| eGFR;Blood Routine;Urine routine;The frequency of acute gout;Blood biochemistry;Urine biochemistry;blood pressure;Ultrasound of urinary system; | — |
Countries
China
Contacts
Public ContactLi Changgui
Affiliated Hospital of Qiingdao University
Outcome results
None listed