gout
Conditions
Interventions
Treatment group:Sodium Bicarbonate + Febuxostat
Control group:Placebo+Sodium Bicarbonate + Febuxostat
Sponsors
Shenzhen Traditional Chinese Medicine Hospital, the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age> 18 years old, <80 years old; 2.Meet the diagnosis of gout (2015 ACR/EULAR gout classification criteria); 3.B-ultrasound suggests kidney stones; 4.Males have no childbearing requirements in the past 6 months; 5.Postmenopausal women (menopause for 2 years), or surgical birth control; 6.Agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Allopurinol, probenecid, benzbromarone, febuxostat, etc. have been used to lower uric acid within 4 weeks before enrollment; 2.Kidney stones larger than 15mm, obstruction (hydronephrosis), pain, and urinary tract infections need to be treated with stones; 3.Patients with secondary hyperuricemia caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy, organ transplantation, etc.; 4.People with a history of cardiovascular and cerebrovascular diseases such as stroke, TIA, MI, HF (NYHA class II-IV), coronary artery surgery (such as angioplasty, stent implantation, bypass grafting, etc.); 5.Patients have had a history of digestive tract ulcers and gastrointestinal bleeding; 6.Patients with active liver disease or abnormal liver function, with AST, ALT or GGT higher than 1.2 times the upper limit of normal; 7.Abnormal renal function, simplified glomerular filtration rate (eGFR) <30ml/min.1.73m^2; 8.Patients with malignant tumors or mental illness; 9.Patients are allergic to or intolerant to febuxostat; 10.Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases accompanied by arthritis; 11.Patients are or need to take azathioprine, mercaptopurine, theophylline and cytotoxic chemotherapy drugs; 12.People who have a history of alcohol or drug dependence, or need long-term daily use of analgesics for any reason; 13.Participate in other clinical research within 3 months before enrollment; 14.There are situations in which various other researchers think it is inappropriate to participate in the clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with reduced kidney stone diameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Simplified glomerular filtration rate;The diameter of kidney stones;Uric Acid;Uric acid standard rate;pH value of urine;Incidence of hypertension;Oedema incidence;Incidence of gout flare; | — |
Countries
China
Contacts
Public ContactJia Ertao
Shenzhen Traditional Chinese Medicine Hospital, the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Outcome results
None listed