gout
Conditions
Interventions
control group:Febuxostat 20mg qd, placebo 6g, bid
experimental group:Febuxostat 20mg qd, Kesuanping 6g, bid
Sponsors
Affiliated Hospital of Qiingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Male, aged between 18 and 70 years; 2) After a 2-week washout period, the patients met the diagnostic criteria for primary gout, with serum uric acid >= 7.0 mg/dL (416µmol/L); 3) eGFR 60 ml/min / 1.73 m2 or 4) No cases of acute gouty arthritis occurred 2 weeks before enrollment and 2 weeks in washout period; 5) Participate voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) People who are known to be allergic to the drugs or ingredients used in this study, or have current allergy, or have high sensitivity; 2) Patients with active liver disease or cirrhosis, or abnormal liver function, with serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceeding 2.5 times the upper limit of the normal range; 3) Biliary tract diseases: patients with biliary tract malformation, cholelithiasis, acute and chronic cholecystitis and cholangitis; 4) Digestive tract diseases: patients with constipation, obstruction and active digestive tract ulcer; 5) Abnormal thyroid function; 6) Patients with severe heart disease, such as: decompensated sex heart failure (NYHA III and IV);Unstable angina pectoris;A history of myocardial infarction in the past 12 months; 7) Patients with xanthuria; 8) Rheumatoid arthritis requiring treatment and joint diseases caused by other reasons; 9) Current treatment with azathioprine, 6-mercaptopurine, cyclosporin, cyclophosphaamide, biazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretic, aspirin (over 325mg/ day) or other salicylic acid substances, losartan, intravenous colchicine; 10) Patients with secondary hyperuricemia caused by blood disease, kidney disease or tumor radiotherapy or chemotherapy; 11) Brain disease, abnormal judgment ability;Mental illness can not cooperate; 12) Alcoholics or drug users; 13) The participants who had participated in other clinical trials within the previous 3 months were screened; 14) Patients with malignant tumor or active tuberculosis; 15) Complicated with other diseases, which the researchers believe may affect efficacy evaluation or poor compliance; 16) Taking glucocorticoid drugs; 17) WBC count < 4.0 x 10^9/L, or platelet < 100 x 10^9/L, or hemoglobin < 90g/L; 18) For any other reason, the investigator deems it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum urate;Intestinal flora;the frequency of gout flare; | — |
Secondary
| Measure | Time frame |
|---|---|
| cre;eGFR;ALT;AST; | — |
Countries
China
Contacts
Public ContactLiChanggui
16 Jiangsu Road, Shinan District, Qingdao, Shandong
Outcome results
None listed