Gout
Conditions
Sponsors
Shenzhen Traditional Chinese Medicine Hospital, the fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years(the time when informed consent is obtained), gender is not limited; 2. Agree to participate in this study and sign an informed consent form; 3. In the past, it complies with the 2015 American Academy of Rheumatology/European Anti-Rheumatic Alliance Gout Classification Standard; 4. sUA > 420umol/L,the number of acute gout attacks in the 12 months before enrollment was >= 2 times/year, or there was tophi; or the sUA >= 480umol/L; 5. Postmenopausal women (menopause for 2 years), or surgical birth control; 6. Belong to be the Rheumatic arthralgia.
Exclusion criteria
Exclusion criteria: 1. Acute gout attacks occurred within 2 weeks before enrollment; 2. Have used colchicine, glucocorticoids, NSAIDs within 2 weeks before enrollment; 3. Patients who have used allopurinol, probenecid, benzbromarone, febuxostat or intra-articular injection of glucocorticoid within 2 weeks before enrollment; 4. Patients with tophi ruptured before enrollment; 5. Patients with secondary hyperuricemia caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy, organ transplantation, etc.; 6. 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.); 7. Patients who have had a history of digestive tract ulcers and gastrointestinal bleeding; 8. Patients with active liver disease or abnormal liver function, with AST, ALT or GGT higher than 1.2 times the upper limit of normal; 9. Abnormal renal function, serum creatinine concentration (sCr) is 1.2 times higher than the upper limit of normal; 10. Patients with malignant tumors or mental illness; 11. Patients who are allergic or intolerant to any ingredients in Febuxostat, Colchicine, Zhengqing Fengtongning Sustained-Release Tablets and test drug excipients; 12. NSAIDs cause asthma, urticaria or other allergies; 13. Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases accompanied by arthritis; 14. Patients who were taking Zhengqingfengtongning sustained-release tablets at the time of enrollment; 15. Patients who are or need to take azathioprine, mercaptopurine, theophylline and cytotoxic chemotherapy drugs; 16. Patients who have a history of alcohol or drug dependence, or need to use analgesics daily for a long time for any reason; 17. Participated in other clinical research within 3 months before enrollment; 18. There are various other researchers who think it is inappropriate to participate in the clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of gout flares; | — |
Secondary
| Measure | Time frame |
|---|---|
| average VAS pain score;proportion of subjects with >=1 and >=2 gout flares within 12 weeks;dosage of etoricoxib;uric acid compliance rate;the rate of gout flares per patient;duration of each gout flares; | — |
Countries
China
Contacts
Public ContactZhang Jianyong
Shenzhen Traditional Chinese Medicine Hospital; and the fourth Clinical Medical College of Guangzhou University of Chinese Medicine
Outcome results
None listed