The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

Amway

Status: Enrolling

Conditions: Hyperuricemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Study Product A (High-dose 2X); Dietary Supplement: Study Product B (Low-dose X)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06084585

22-RB-07-AY-001

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Study Product A (High-dose 2X)

Active Comparator group

Description:

Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: * Celery seed (functional raw material) * Dasiphora mandshurica (functional raw material) * Cichorium intybus L. (functional raw material) * Lotus leaf (functional raw material) * Tart cherry (functional raw material) * γ-cyclodextrin * Erythritol * Silicon dioxide * Resistant dextrin * Black tea essence

Treatment:

Dietary Supplement: Study Product A (High-dose 2X)

Study Product B (Low-dose X)

Active Comparator group

Description:

Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: * Celery seed (functional raw material) * Dasiphora mandshurica (functional raw material) * Cichorium intybus L. (functional raw material) * Lotus leaf (functional raw material) * Tart cherry (functional raw material) * γ-cyclodextrin * Erythritol * Silicon dioxide * Resistant dextrin * Black tea essence

Treatment:

Dietary Supplement: Study Product B (Low-dose X)

Placebo

Placebo Comparator group

Description:

Placebo product: 5g/sachet, containing the following active ingredients: * Maltodextrin * Pigment * Erythritol * Bitters * Essence of flavor

Treatment:

Dietary Supplement: Placebo