Gouty arthritis
Conditions
Interventions
Medicine group:Febuxostat (40mg/ tablet, manufactured by Jiangsu Hengrui Pharmaceutical Co., LTD., batch number 210727JA) was started at 20 mg/d. After 4 weeks, the serum uric acid level was still not
TCM group :The traditional Chinese medicine group was treated with decoction for removing dampness and reducing turbidity, which was provided by the outpatient Chinese medicine pharmacy of our hospita
Medicine+TCM group:Meicine+TCM:febuxostat (40mg/ tablet, Jiangsu Hengrui Pharmaceutical Co., LTD., batch number 210727JA), the initial dose was 20 mg/d, after 4 weeks, the blood uric acid level still
damp-heat syndrome of the spleen and stomach:none
Non damp-heat syndrome of the spleen and stomach:none
Sponsors
Affiliated Second People's Hospital of Fujian University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age range of 18-75 years, gender unrestricted. (2) Traditional Chinese Medicine (TCM) diagnosis of gouty arthritis refers to the "Diagnostic Criteria, Syndrome Classification, and Efficacy Evaluation of Gout," and the differentiation criteria for damp-heat syndrome of the spleen and stomach refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" (Volume 1). Western medical classification standards are based on the gout classification criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). (3) Discontinuation of other Chinese herbal medicines, maintaining stability of the baseline treatment regimen for at least 4 weeks. (4) Baseline screening indicates normal liver and kidney function in the subjects. (5) Voluntarily signing an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known or suspected secondary hyperuricemia. (2) Allergy to any of the drug components used in this study. (3) Acute gout attack during screening or within the two weeks prior to screening. (4) Other chronic arthritis conditions (non-gout), acute inflammatory arthritis, autoimmune arthritis. (5) Coronary intervention procedures (including but not limited to angioplasty, stent placement, coronary artery bypass grafting), history of stroke, transient ischemic attack, intracranial venous thrombosis, recent myocardial infarction, congestive heart failure (NYHA class II-IV), or other cardiovascular diseases. (6) Pregnant or lactating women. (7) Human immunodeficiency virus (HIV) positive; active pulmonary tuberculosis; untreated chronic hepatitis B patients or carriers with chronic hepatitis B virus (HBV) DNA levels exceeding 500 IU/mL; active hepatitis C patients should be excluded. Non-active HBV carriers, stable hepatitis B patients (HBV DNA <500 IU/mL) under treatment, and cured hepatitis C patients can be included. Hepatitis C virus (HCV) antibody-positive individuals can participate only if HCV RNA is negative. (8) Known history of mental drug abuse, substance abuse, or alcoholism. (9) Concurrent use of theophylline, sulfinpyrazone, or allopurinol and cannot be discontinued. (10) Any other condition that the investigator deems necessary to exclude the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uric Acid,UA;Number of relapses; | — |
Secondary
| Measure | Time frame |
|---|---|
| triglyceride,TC;cholesterol;urine pH;VAS score and pain relief; | — |
Countries
China
Contacts
Public Contactwu fangzhen
Affiliated Second People's Hospital of Fujian University of Traditional Chinese Medicine
Outcome results
None listed