The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

Last updated: October 10, 2023
Sponsor: Amway (China) R&D Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gout (Hyperuricemia)

Treatment

Placebo

Study Product A (High-dose 2X)

Study Product B (Low-dose X)

Clinical Study ID

NCT06084585
22-RB-07-AY-001
  • Ages 18-65
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants aged between 18 and 65 years old (mostly above 35 years old), includingmale and female and the ratio of male to female is not limited;
  • Patients with hyperuricemia: meet the diagnostic criteria set out in the "ChineseGuidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)", and fastingblood uric acid level exceeds 420 μmol/L twice on different days. Furtherclassification using the Janssens Gout Diagnostic scale included asymptomatichyperuricemia (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 duringthe study, or they will be eliminated
  • Participants understand the test procedure, read, and sign an appropriate InformedConsent Form indicating their willingness to participate.

Exclusion

Exclusion Criteria:

  • Secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapyand chemotherapy;
  • Subjects who are using drugs during gout attacks;
  • Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoieticsystem, 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 oraspartate aminotransferase; Serum creatinine was higher than the upper limit of thenormal range;
  • Allergic to the test drug or weak or allergic;
  • Pregnant or lactating women or those who have pregnancy plans; Sex hormone replacementtherapy 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.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
March 15, 2024

Connect with a study center

  • Charlie Zhang

    Jinhua, Zhejiang
    China

    Active - Recruiting

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