A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change of Serum Uric Acid Level
研究概览
简要总结
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 years old. The main question it aims to answer is:
- whether the serum uric acid level of patients with hyperuricemia could be significantly lowered after 3 months intervention with Amway uric acid lowering product
180 eligible participants will be enrolled in one study site and randomized to three study groups (two product group and one placebo group), who will consume the assigned products for 3 months and be arranged to 3 site visits. All relevant clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis and reporting.
Researchers will compare the three study groups to conclude how Amway uric acid lowering product will improve hyperuricemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of Serum Uric Acid Level
时间窗: baseline, and 12 weeks
Change of Serum Uric Acid Level from baseline to 12 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days
次要结局
- Change of Serum Uric Acid Level(baseline, and 6 weeks)
- Fractional Excretion of Uric Acid (FEUA)(baseline, 6 weeks, and 12 weeks)