gout
Conditions
Interventions
experimental group: The subjects in the experimental group were given 20g of Hushen Tongfengtai Granules three times a day and 20mg of febuxostat once a day orally
control group:The subjects in the control group were given only 20mg of febuxostat once a day orally
Sponsors
Shenzhen Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 75 years old (at the time of obtaining informed consent), gender unrestricted; 2) Previously met the gout classification criteria established by ACR/EULAR in 2015; 3) TCM syndrome differentiation conforms to "kidney deficiency with damp-heat syndrome"; 4) Serum uric acid level > 7.0 mg/dL (420 µmol/L) at the time of enrollment; 5) Voluntary participation, able to cooperate with regular follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with acute gout attacks within one week before enrollment; 2) Patients with gouty tophi rupture before enrollment; 3) Patients with secondary hyperuricemia caused by kidney disease, blood disease, certain medications, tumor radiotherapy and chemotherapy, organ transplantation, etc.; 4) Patients who have used allopurinol, probenecid, benzbromarone, febuxostat and other uric acid-lowering drugs within four weeks before enrollment; 5) Patients with a history of stroke, TIA, MI, HF (NYHA class II-IV), coronary artery surgery (such as angioplasty, stent implantation, bypass grafting, etc.) and other cardiovascular and cerebrovascular diseases; 6) Patients with diabetes; 7) Patients with active liver disease or abnormal liver function, with AST, ALT or GGT levels above the upper limit of normal; 8) Patients with abnormal renal function, with serum creatinine concentration (Scr) above the upper limit of normal; 9) Patients with malignant tumors or mental illness; 10) Patients allergic or intolerant to any component of the excipients of the test drug; 11) Patients with other chronic arthritis, acute inflammatory arthritis, or autoimmune diseases with arthritis; 12) Patients currently taking or needing to take azathioprine, mercaptopurine, theophylline and cytotoxic chemotherapy drugs; 13) Pregnant, lactating women or those planning to become pregnant within three months after the last study drug administration; 14) Patients who have participated in other clinical studies within three months before enrollment; 15) Patients with other conditions that the investigator deems unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving a serum uric acid level = 6.0 mg/dL (360 µmol/L) at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The decrease in serum uric acid levels (i.e., the difference from the baseline value) at 4, 8, and 12 weeks of treatment.;The rate of achieving a blood uric acid level = 6.0 mg/dL (360 µmol/L) at 4 and 8 weeks of treatment;The maximum percentage change in serum uric acid levels from baseline to week 12;The proportion of subjects reporting gout attacks (cumulative up to each visit);The number of gout attacks within 12 weeks of the treatment period (i.e., the total number of gout attacks among the subjects in a single group);The duration of each acute gout attack within the 12-week treatment period;Changes in anthropometric parameters (weight, waist circumference, BMI) from baseline to week 12 (combined with obese individuals); | — |
Countries
China
Contacts
Public ContactXie Jingjing
Shenzhen Traditional Chinese Medicine Hospital
Outcome results
None listed