Hyperuricemia
Conditions
Interventions
High dose group:Astragalus and Poria Granules: 3 packs per dose
3 times per day
continuous administration for 12 weeks
Low-dose group:Astragalus and Poria Granules: 3 packs per dose
2 times per day
Sponsors
Hangzhou Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age = 80 years old; 2. Meets the 2019 Western medicine diagnostic criteria for "hyperuricemia" as outlined in the "China Hyperuricemia and Gout Management Guidelines (2019)"; 3. Meets the diagnostic criteria for "spleen deficiency or damp-heat stasis"; 4. Fasting serum uric acid levels > 420 µmol/L within 3 months prior to enrollment, and meets one of the following conditions: 1) Has a history of hyperuricemia (HUA), no complications, baseline fasting serum uric acid level = 9.0 mg/dL (540 µmol/L); 2) Has a history of HUA with one or more of the following conditions (hypertension, dyslipidemia, diabetes, obesity, stroke, coronary heart disease, heart failure, uric acid nephrolithiasis, renal impairment (= CKD stage 2)), baseline fasting serum uric acid level = 8 mg/dL (480 µmol/L) and maintains previous treatment during the trial; 3) Has a history of gout, no complications, baseline serum uric acid level = 8.0 mg/dL (480 µmol/L); 4) Has a history of gout with one or more of the following conditions (= 2 gout attacks per year, tophi, chronic gouty arthritis, kidney stones, chronic kidney disease, hypertension, diabetes, dyslipidemia, stroke, ischemic heart disease, heart failure, and onset age < 40 years), baseline serum uric acid level = 7 mg/dL (420 µmol/L) and maintains previous treatment during the trial. 5. CKD stage < IV (glomerular filtration rate = 30 ml/min/1.73m²); 6. Obtains voluntary informed consent from the participant, approved by the ethics committee, prior to the start of the trial.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Severe hepatic insufficiency (ALT > 3 times the upper limit of normal range); 3. Patients who have had acute gout attacks within the past 2 weeks; 4. Secondary hyperuricemia patients (including organ transplant recipients patients with bone marrow dysplasia chronic renal insufficiency-induced cases etc.); 5. Discontinuation of uric acid-lowering drugs such as allopurinol benzbromarone febuxostat or other uric acid-lowering traditional Chinese medicines < 2 weeks ago; 6. Hypertensive patients whose blood pressure remains =180 mmHg systolic and/or =110 mmHg diastolic despite active antihypertensive treatment; 7. Diabetic patients with acute complications such as diabetic ketoacidosis hyperosmolar nonketotic diabetic coma etc.; 8. Patients with severe heart lung central nervous system diseases or malignant tumors; 9. Patients with mental illness or intellectual disabilities who cannot accurately describe their own sensations; 10. Allergic constitution or allergic to the investigational drug or any component of the investigational drug; 11. History of alcohol abuse or alcohol intake exceeding 7 times per week drug addiction or drug abuse; 12. History of xanthinuria; 13. Patients who have participated in any drug trial within 3 months prior to enrollment; 14. Patients whom the investigator considers unsuitable for inclusion in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving the target for serum uric acid control;The change in blood uric acid from baseline at the last visit;The difference in blood uric acid levels from baseline at each visit point; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary protein-creatinine ratio, urinary albumin-creatinine ratio, urinary NAG (N-acetyl-ß-D-glucosidase)-creatinine ratio, urinary a1-microglobulin-creatinine ratio;;The number of acute gout attacks and the number of acute gout attacks requiring therapeutic intervention;Fasting blood glucose level;Biochemistry panel (UA TC TG LDL-C HDL-C GLU CK CRP IL-6 potassium sodium chloride magnesium calcium phosphorus);Estimated Glomerular Filtration Rate (eGFR) creatinine (Cr) urea and blood urea nitrogen (BUN); | — |
Countries
China
Contacts
Public ContactJin Jianhong
Hangzhou Traditional Chinese Medicine Hospital
Outcome results
None listed