Gout
Conditions
Interventions
2:Diclofenac 75mg, b.i.d
1:Diclofenac 75mg, b.i.d, + Febuxostat 40mg/d
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 70 Years
Inclusion criteria
Inclusion criteria: (1) Acute gout attack 50 years), or surgical birth control, or within 30 days after the last dose of this study, within the study, take a medically acceptable method of contraception. Including oral or injectable hormones or installing IUDs or taking both methods; (6) Serum creatinine (SCr) is less than or equal to the upper limit of normal.
Exclusion criteria
Exclusion criteria: Potential subjects who meet the inclusion criteria will be excluded if any of the following are met: (1) Pregnant or lactating women and women planning to become pregnant who are unwilling or not taking adequate contraceptive measures; male patients who are unwilling or not taking adequate contraceptive measures; (2) Body mass index (BMI) greater than 30.0; BMI = weight (kg)/height^2 (m) (height squared); (3) Sex hormone replacement therapy and oral contraceptive therapy have been conducted within the past 3 months; (4) Must use the banned drugs prescribed in the plan; (5) Active liver disease, or abnormal liver function, AST or ALT higher than the upper limit of the normal range; (6) There is a long history of application of glucocorticoids, and the daily application dose is equivalent to prednisone = 10 mg; (7) Have a history of alcohol abuse or alcohol intake more than 7 times per week; (8) Secondary hyperuricemia (eg, kidney disease, blood disorders, etc.) (9) White blood cell count (WBC) <4.0 x 10^9/L, platelet count (PLT) <100×10^9/L, hemoglobin (HGB) <90 g/L; (10) Those who are allergic to febuxostat and diclofenac; (11) Active peptic ulcer; (12) Patients with a history of malignancy (excluding basal cell carcinoma of the skin) or systemic anti-cancer chemotherapy within the first 5 years of the screening period; (13) Those diagnosed with other rheumatic immune system diseases, such as rheumatoid arthritis, systemic erythematosus, ankylosing spondylitis, etc.; (14) Have experienced myocardial infarction or stroke, and patients with congestive heart failure; (15) Those who received other study drugs 3 months before screening; (16) Those who are unable or unwilling to provide informed consent or fail to comply with the test requirements; (17) Researchers consider it inappropriate to participate in the owner of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gout inflammation duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum uric acid;Pain VAS score;Local skin temperature;Erythrocyte sedimentation rate;C-reactive protein; | — |
Countries
China
Contacts
Public ContactErtao Jia
Shenzhen Traditional Chinese Medicine Hospital, the fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen
Outcome results
None listed