Status:
UNKNOWN
The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
Lead Sponsor:
Amway (China) R&D Center
Conditions:
Hyperuricemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this three arms, randomized, double-blind controlled interventional study is to evaluate the efficacy of Amway uric acid lowering product improving hyperuricemia in patients aged 18 and 65...
Eligibility Criteria
Inclusion
- Participants aged between 18 and 65 years old (mostly above 35 years old), including male and female and the ratio of male to female is not limited;
- Patients with hyperuricemia: meet the diagnostic criteria set out in the "Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)", and fasting blood uric acid level exceeds 420 μmol/L twice on different days. Further classification using the Janssens Gout Diagnostic scale included asymptomatic hyperuricemia (that is, never had a gout attack) and patients with a history of gout, with a ratio of about 1:1;
- Participants agree not to take any drugs, supplements, or performance enhancers during the study, or they will be eliminated
- Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.
Exclusion
- Secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapy and chemotherapy;
- Subjects who are using drugs during gout attacks;
- Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients;
- Severe obesity (BMI\>32kg/m2);
- Abnormal liver and kidney function: abnormal level of alanine aminotransferase or aspartate aminotransferase; Serum creatinine was higher than the upper limit of the normal range;
- Allergic to the test drug or weak or allergic;
- Pregnant or lactating women or those who have pregnancy plans; Sex hormone replacement therapy and oral contraception in the past 3 months;
- Subjects who have participated in other research projects within three months;
- Subjects that other researchers considered should be excluded.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06084585
Start Date
October 23 2023
End Date
March 15 2024
Last Update
October 16 2023
Active Locations (1)
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1
Charlie Zhang
Jinhua, Zhejiang, China