Gout
Conditions
Interventions
Berberine treatment group:Receiving berberine treatment
Colchicine treatment group:Receiving colchicine treatment
Sponsors
The First Affiliated Hospital of Chengdu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years (inclusive), any gender. (2) Meet the Western medicine diagnostic criteria for gouty arthritis. (3) Pain of the current acute attack is located in the joint(s) of the upper and/or lower extremities. (4) Onset of the current acute attack is within 48 hours prior to enrollment. (5) If receiving urate-lowering therapy, the dose must have been stable for at least 2 weeks prior to enrollment, and the treatment regimen must remain unchanged throughout the study. (6) Voluntarily participate in the study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Intercritical period of gout. (2) Complicated by acute rheumatic fever, septic arthritis, traumatic arthritis, pseudogout, rheumatoid arthritis, spondyloarthritis, or other autoimmune or inflammatory arthritis; or complicated by soft tissue swelling and pain of the lower extremities, such as erysipelas, lower extremity phlebitis, or diabetic foot; or complicated by any other disease that may affect the assessment of efficacy. (3) Patients with severe cardiovascular or cerebrovascular diseases, autoimmune diseases, malignant tumors, hematological diseases, digestive system diseases, or other organic diseases; or patients with psychiatric disorders. (4) Accompanied by severe hepatic or renal diseases, or abnormal liver or kidney function tests (ALT, AST, or total bilirubin = 2× upper limit of normal [ULN]; serum creatinine > 1.2× ULN). (5) Use of medications that may affect the efficacy evaluation within 48 hours prior to enrollment, including non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and traditional Chinese medicine preparations. (6) Pregnant or lactating women, or male or female subjects who plan to conceive during the trial period or within 3 months after the last administration of the investigational drug. (7) Known allergy or hypersensitivity to any component of the investigational drug. (8) Suspected or confirmed history of alcohol or drug abuse. (9) Subjects deemed unsuitable for participation in this clinical trial by the investigator for any other reasons (such as conditions that may prevent the subject from completing the trial or pose significant risks to the subject).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale score; | — |
Countries
China
Contacts
Public ContactWantai Dang
The First Affiliated Hospital of Chengdu Medical College
Outcome results
None listed