Gout
Conditions
Interventions
Control Group:Febuxostat+Mineral water: Febuxostat 20/40 mg qd +Mineral water 6 bottles qd
Trial Group:Febuxostat+Small molecule alkaline water: Febuxostat 20/40 mg qd +Small molecule alkaline water 6 bottles qd
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old to 75 years old, male. 2. Obtain the consent of the subject, or family member, or guardian, or legal representative and sign the informed consent form. 3. Meet the clinical diagnostic criteria for gout (the scoring diagnostic criteria for 2015 ACR/ELUAR), have not used uric acid-lowering drugs in the two weeks prior to randomization, and have experienced remission of acute gout attacks for at least two weeks; 4. The blood uric acid value is >=540 µmol/L (9 mg/dL), and the WHR is <=0.95. 5. The condition of other concomitant diseases (such as hypertension, hyperlipidemia, diabetes, etc.) is stable, and the dosage of medication remains unchanged throughout the trial period. 6. Participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic or contraindicated to all the drugs or ingredients used in this test, or have existing allergic or hypersensitive constitution; 2. Acute gouty arthritis within 2 weeks before randomization authors; 3. Use of urico-lowering drugs within 2 weeks before randomization; 4. Use or plan to use corticosteroids, antituberculosis drugs (e.g., ethambutol, pyrazinamide), anticoagulants (e.g., warfarin or other coumarin-based anticoagulants, bivaluludine), immunosuppressants (e.g., cyclosporine, tacrolimus), aspirin or other salicylic acid substances, azathioprine, 6-mercaptopurine, cyclophosphamide, Sulfamethoxazole, trimethoprim, theophylline, niacin, estrogen and other drugs that affect uric acid metabolism; 5. Active stage of peptic ulcer, thyroid dysfunction, malignancy, active tuberculosis, or urinary tract stones; 6. Diagnosed arthritis due to rheumatic fever, rheumatoid arthritis, other rheumatic immune diseases, or osteoarthritis requiring analgesic therapy; 7. Heart failure with limited activity (previously diagnosed, or with clinical manifestations of heart failure confirmed by cardiology consultation), unstable angina pectoris, history of myocardial infarction within the past 12 months, or other severe heart disease; 8. Secondary hyperuricemia caused by hematological diseases, malignant tumors, renal diseases, or tumor radiotherapy/chemotherapy; 9. For patients with severe renal insufficiency (eGFR 2×ULN, or total bilirubin (TBIL) >= 2×ULN]; 11. Poorly controlled severe hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) despite treatment; 12. Patients currently receiving hypoglycemic therapy or not receiving such therapy but with HbA1c > 8%; 13. White blood cell count < 3.5×10^9/L, or platelet count < 100×10^9/L, or hemoglobin < 90 g/L; 14. Cerebral disease, impaired judgment, or psychiatric disorder leading to inability to cooperate; 15. History of alcohol abuse or illicit drug use; 16. Pregnant, breastfeeding, or planning to become pregnant (including male subjects); 17. Participation in another clinical trial within 3 months prior to screening for this trial; 18. Other conditions considered by the investigator as unsuitable for trial participation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Achievement rate of serum uric acid (SUA) level =300 µmol/L at 24 weeks;Changes in blood pressure, BMI, body fat percentage, waist-to-hip ratio during 24-week period;Number of gout flares and percentage of patients with gout flares during 24-week period;Average uric acid level and frequency of gout flares during 24-week period;Changes in serum uric acid, lipid profile, blood glucose, urine pH, tophus volume, and kidney stone volume during 24-week period;Change in urine pH from baseline at last visit;Changes in blood pressure, BMI, waist-to-hip ratio, and body fat analysis at last visit;Number of acute gout flares and percentage of patients with acute gout flares at last visit;Change from baseline in serum uric acid, blood glucose, and lipid profile (triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein) at last visit;Change in tophus volume and kidney stone volume from baseline at last visit; | — |
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of serum uric acid level below 360 µmol/L at last visit; | — |
Countries
China
Contacts
Public ContactLi Changgui
The Affiliated Hospital of Qingdao University
Outcome results
None listed