Acute Gouty Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Only those who meet all the following requirements can be included in this trial. 1)In accordance with the 2015 gout diagnostic criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), and based on the "Guidelines for Integrated Traditional Chinese and Western Medicine in the Diagnosis and Treatment of Gout and Hyperuricemia (2023)," the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine," and the "Guiding Principles for Clinical Research of New Chinese Medicines," the diagnosis aligns with traditional Chinese medicine diagnoses of "gout" and "damp-heat toxin accumulation syndrome," and the stage is classified as acute gouty arthritis. 2)Traditional Chinese medicine distinguishes it as the syndrome of damp-heat and toxin accumulation; 3)Age is between 18 and 60 years old, regardless of gender; 4)Voluntarily participate in clinical research and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Individuals with any of the following conditions will be excluded from this study: 1)Known allergies to the trial drug; 2)Undergoing dialysis treatment; 3)Concurrent hyperkalemia, heart failure, uremia, or other life-threatening conditions; 4)Primary disease being obstructive nephropathy; 5)Mental illness; 6)Pregnant or lactating women; 7)Coexistence of serious primary diseases in the brain, cardiovascular system, liver or hematopoietic system; 8)Undergone major or medium surgery within 3 months prior to the screening examination; 9)Have taken other anti-inflammatory and analgesic drugs (non-steroidal anti-inflammatory drugs, colchicine, and corticosteroids) within 2 weeks before the treatment; 10)Have taken other trial drugs or participating in other clinical studies within 1 month prior to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint Pain Rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint Swelling Rating;Joint Function Rating;Quantitative Score of Traditional Chinese Medicine (TCM) Syndrome;Serum C-reactive Protein;Erythrocyte Sedimentation Rate;Serum Uric Acid;Musculoskeletal Ultrasound Indices;IL-1;IL-6;TNF-a; | — |
Countries
China
Contacts
Shuguang Hospital affiliated to Shanghai University of T.C.M