Hyperuricemia (Asymptomatic or Gout)
Conditions
Interventions
Qiling granule low dose group:A low dose of Qiling granules was taken, 3 packs each time, twice daily
Qiling granule high dose group:A high dose of Qiling granules was taken, 3 packs each time, 3 times a day
Sponsors
Hangzhou Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.18 years old = age =80 years old; 2. In accordance with the 2019 western medicine diagnostic criteria of "hyperuricemia", the Chinese Guidelines for the diagnosis and Treatment of hyperuricemia and Gout (2019); 3. In accordance with the syndrome differentiation criteria of "spleen deficiency or damp-heat stasis" (" Guiding Principles for Clinical Research of New Chinese Medicine (2002 edition) "and" Diagnosis, syndrome differentiation Classification and Efficacy evaluation of uric acid Nephropathy (Trial Scheme) "); Main symptoms: fatigue, poor stool, joint swelling or pain. Secondary symptoms: heavy body, mouth is not thirsty or thirsty to drink, eat less and stay, abdominal fullness, or urination. Tongue pulse: tongue texture is light or red, with tooth marks, thin or yellow coating, slow or soft pulse. 3 items of main evidence (tongue coating is required); Or 2 main syndromes, plus 2 secondary syndromes (tongue coating is necessary) can be diagnosed. 4. Fasting serum uric acid level > 420µmol/L within 3 months before enrollment and one of the following conditions: 1) patients with a history of hyperuricemia and no comorbidities, with a baseline fasting serum uric acid level =9.0mg/dL(540µmol/L); 2) patients with a history of hyperuricemia combined with one of the following conditions (hypertension, abnormal lipid metabolism, diabetes mellitus, obesity, stroke, coronary heart disease, cardiac insufficiency, uric acid nephrolithiasis, or renal impairment (=CKD2)), with a fasting serum uric acid level =8mg/dL (480µmol/L) at baseline and maintained on previous treatment during the trial; 3) patients with a history of gout without comorbidities and baseline serum uric acid level =8.0mg/dL(480µmol/L); 4) patients with a history of gout combined with one of the following conditions (gout attack =2 times/year, tophi, chronic gouty arthritis, kidney stones, chronic kidney disease, hypertension, diabetes, dyslipidemia, stroke, ischemic heart disease, heart failure and onset age < 40 years); The baseline serum uric acid level was at least 7mg per deciliter (420µmol per liter) and previous treatment was maintained during the trial. 5. Prior to the initiation of the trial, the subjects voluntarily signed informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Pregnant or lactating women; 2. Severe liver dysfunction (ALT > 3 times upper limit of normal range); 3. Author of acute gout attack in recent 2 weeks; 4. Patients with secondary hyperuricemia (including organ transplant recipients, myelodysplasia, chronic renal insufficiency, etc.); 5. Stopping urate-lowering drugs such as allopurinol, benzbromarone, febuxostat, etc., or other urate-lowering traditional Chinese medicine for less than 2 weeks; 6. Estimated glomerular filtration rate < 30ml/min/1.73m2; 7. Hypertensive patients with systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg after active antihypertensive treatment; 8. Patients with acute diabetic complications, such as diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, etc. 9. Patients with serious heart, lung, central nervous system diseases or malignant tumors; 10. People with mental illness or intellectual disability who cannot correctly describe their feelings; 11. Allergy, or allergy to the study drug or any component of the study drug; 12. Having a history of alcohol abuse or alcohol intake more than 7 times per week, drug abuse or drug abuse; 13. A history of xanthinuria; 14. Participants who had participated in any drug trial within 3 months before enrollment; 15. Others were deemed by the investigator to be ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in blood uric acid from baseline at last visit;Blood uric acid control up to standard rate;Blood uric acid difference from baseline at each site; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;The number of acute gout episodes and the number of acute gout episodes requiring therapeutic intervention;Fasting blood glucose level;blood biochemistry;Urinary creatinine ratio;Urinary albumin creatinine ratio;Urinary NAG (n-acetyl-beta-D-glucosidase) creatinine ratio;Urinary a1-microglobulin creatinine ratio;eGFR;Cr;Urea;BUN; | — |
Countries
China
Contacts
Public ContactJin Jianhong
Hangzhou Traditional Chinese Medicine Hospital
Outcome results
None listed