gout
Conditions
Interventions
Control group:placebo
Experimental group:Total glucosides of paeony capsule
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meets the 2015 ACR/EULAR gout classification criteria and has been clearly diagnosed with gout by the investigator; 2. Aged between 18 and 70 years (inclusive), any gender; 3. Based on medical history and/or records, has had >=2 investigator-confirmed acute gout flares in the 12 months prior to the screening period; 4. Serum uric acid (sUA) >=480 µmol/L at screening; 5. Background therapy: initiation of standard urate-lowering treatment regimen (excluding febuxostat, starting at 40 mg/day).
Exclusion criteria
Exclusion criteria: 1. At screening or within 4 weeks before randomization, in the acute attack phase of gout; 2. Patients who require long-term (more than 4 weeks of continuous use) or unstable use of systemic glucocorticoids (such as prednisone daily dose > 5mg or equivalent); 3. Severe cardiovascular disease (NYHA cardiac function grade III.-IV.), uncontrolled hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg); 4. Liver insufficiency (ALT or AST> 2 times the upper limit of the normal range); 5. Renal insufficiency (eGFR<=60ml/min); 6. Subjects with chronic diarrhea, inflammatory bowel disease, or other serious gastrointestinal diseases that may affect drug absorption or evaluation; 7. The blood white blood cell < of the study participant is 2.0×10^9/L, or has definite anemia (hemoglobin less than 80g/L), or platelet < 60×10^9/L, or has other hematological diseases; 8. Those who have a history of allergy to total peony glycosides or any excipient components of this study drug; 9. Pregnant or lactating women, or those who have a pregnancy plan within six months; 10. Combined with malignant tumors; 11. Those with mental illness or intellectual disability who cannot correctly describe their feelings or record medication; 12. Suffering from other inflammatory diseases that may cause arthritis (such as rheumatoid arthritis, psoriatic arthritis, etc.); 13. Secondary hyperuricemia, such as caused by myeloproliferative diseases, tumor lysis syndrome, etc.; 14. Participated in any other clinical trial of any drug or medical device within 3 months before the screening period; 15. Any condition that may affect the safety of the study participants or the interpretation of the results of the study (such as history of alcohol/drug abuse, mental illness, etc.) in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gout flare; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score for acute gout attack pain;Number of acute gout attacks within 4 weeks;Total duration of acute gout attacks during the study period;The time span from patient enrollment to the first occurrence of an acute gout attack (in days); | — |
Countries
China
Contacts
Public ContactZhu Xiaoxia
Huashan Hospital, Fudan University
Outcome results
None listed