hyperuricemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with 18-65 years old, male or female; 2. Patients fulfil the diagnostic criteria for preclinical gout (hyperuricemia); 3. Patients fulfil the diagnostic criteria of spleen deficiency, dampness and turbidity syndrome according to the Interpretation of the Guidelines for Clinical Diagnosis and Treatment of Traditional Chinese Medicine; 4. Patients with blood uric acid level =480µmol/L and complications such as hypertension, abnormal lipid metabolism, diabetes, obesity, coronary heart disease, or simple blood uric acid level =540µmol/L; 5. No patients have a history of acute gout attack, gouty stone formation, uric acid nephropathy and other complications; 6. 15 days before inclusion, no drugs affecting the observation of this study are used, such as phenylbromarone, angiotensin receptor antagonist, angiotensin converting enzyme inhibitor, spironolactone, metformin, etc; 7. Patients voluntarily participate in the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with suspected secondary hyperuricemia such as blood disease, kidney disease, tumor radiotherapy and chemotherapy or history of taking related drugs such as penicillin, cephalosporin, pyrazinamide, hydrochlorothiazide, furthiamide, furanilinic acid, etanilic acid, niacin, cyclosporine, imidazolibin, etc. 2. Patients with severe heart, liver, and kidney diseases, such as malignant arrhythmia, acute coronary syndrome, acute heart failure, severe liver injury, and renal failure. 3. Pregnant or lactating patients. 4. Patients who are contraindicated or allergic to the trial drug. 5. Patients who have participated in other clinical trials in the last 3 months. 6. Patients with severe mental illness. 7. Patients with a history of drug rash or drug allergic reaction. 8. Patients who are currently infected with the epidemic virus and taking antiviral drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood uric acid;standard-achieving rate of blood uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| reduced amount of urate crystal deposition on energy spectrum CT;fluctuation of blood/uric acid;gout conversion rate;average usage of allopurinol;TCM syndrome score;tongue score;time of first acute attack of gout; | — |
Countries
China
Contacts
the First Affiliated Hospital of Hunan University of Chinese Medicine/ Hunan University of Chinese Medicine