Zhengqing Fengtongning Sustained-Release Tablets Prevents Gout Flares in the Process of ULT: a Randomized, Positive Control, Double-Blind, Double-Simulation, Multi-Center Trial

Phase 4

Recruiting

• Conditions: Gout

• Registration Number: ITMCTR2100004701
• Lead Sponsor: Shenzhen Traditional Chinese Medicine Hospital, the fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of gout flares;

Secondary Outcome Measures

Name	Time	Method
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;