A randomized, controlled, single center clinical trial of total glucosides of paeony in the prevention of gout

Phase 4

Recruiting

• Conditions: Gout

• Registration Number: ITMCTR2000003933
• Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Department of Rheumatology and Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. The age of 18-65 years old patients with autonomic activity ability, male patients;
2. The patients who met the diagnostic criteria of gout (American Society of Rheumatology, 1977); the number of gouty arthritis episodes >= 1 in recent half a year;
3. Patients with serum uric acid level >= 8.0 mg / dl (480 µ mol / L);
4. The patients voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria

1. The patients with acute gouty arthritis within one month before enrollment; patients with acute gouty arthritis more than 6 times or single attack duration >= 2 weeks in one year before enrollment;
2. Patients with active liver disease or abnormal liver function (ALT and AST are 2 times or more of the upper limit of normal value), and patients with impaired renal function (CR value exceeding the upper limit of normal value);
3. Subjects with white blood cell < 4.0 x 10^9 / L, anemia (hemoglobin less than 100g / L), platelet < 100 x 10^9 / L, or other blood system diseases;
4. Patients with serious heart, lung, central nervous system disease or malignant tumor;
5. Patients with mental illness or mental retardation who can not correctly describe their own feelings or cannot take medicine according to the doctor's advice;
6. Patients with hypertension and diabetes mellitus;
7. Patients with chronic diffuse connective tissue disease;
8. Patients with active peptic ulcer history in recent one year;
9. Patients with history of alcoholism, drug abuse or drug abuse in recent one year;
10. Patients who need to use the prohibited drugs prescribed in the protocol during the trial period;
11. Patients with allergic constitution or allergic to research drugs;
12. Patients in the control group were randomly assigned to other drugs such as norbutamol or norbutamol within 4 weeks;
13. Patients who participated in clinical trials of other drugs within 30 days before screening.
14. In addition to the above criteria, the investigator or Assistant Investigator determined that the patient was not suitable for the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood uric acid;

Secondary Outcome Measures

Name	Time	Method
Blood chemistry;Blood routine;Urine routine;