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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003933
Enrollment
Unknown
Registered
2020-09-16
Start date
2020-11-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

A:Paeonia total glycosides capsule 0.6g Tid
C:Febuxostat capsules 20mg Qd + total glucosides of paeony capsules 0.6g tid
B:Blank control group
D:Febuxostat capsules 20mg Qd

Sponsors

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Department of Rheumatology and Immunology
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Blood uric acid;

Secondary

MeasureTime frame
Blood chemistry;Blood routine;Urine routine;

Countries

China

Contacts

Public ContactJinhui Tao

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

taojinhui@ustc.edu.cn+86 18963799313

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026