Evaluating Amway's product for lowering uric acid in patients with high uric acid levels

A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

This study is testing if an Amway product can help lower uric acid levels in adults aged 18 to 65 who have high uric acid.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Amway (China) R&D Center (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jinhua, Zhejiang)
• Trial ID: NCT06084585 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the efficacy of an Amway uric acid lowering product in patients aged 18 to 65 with hyperuricemia. It involves a randomized, double-blind, controlled design with three arms: two groups receiving different doses of the product and one placebo group. Over three months, participants will consume the assigned products and attend three site visits for monitoring and data collection. The primary outcome is the change in serum uric acid levels after the intervention period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with diagnosed hyperuricemia, as defined by specific clinical guidelines.

Not a fit: Patients with secondary gout due to underlying conditions or those currently taking medications that affect uric acid levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective dietary supplement for managing hyperuricemia, potentially reducing the risk of gout and related complications.

How similar studies have performed: While there have been studies on uric acid management, the specific use of Amway's product in this context is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Jinhua, Zhejiang

• Charlie Zhang — Jinhua, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Dan Cao, MD — Jinhua Wenrong Hospital
• Study coordinator: Charlie Zhang, MD

Conditions Hyperuricemia; Uric Acid; Amway