An interventional study of Study Product A (High-dose 2X) and Study Product B (Low-dose X) in Hyperuricemia, sponsored by Amway (China) R&D Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Amway (China) R&D Center · Not applicable, Interventional, and Supportive care
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.
221 studies on the registry are indexed under Hyperuricemia; 41 are open to participants now.
This study's planned enrollment of 180 is above the median of 64 across 177 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Amway (China) R&D Center is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
Dietary Supplement: Study Product A (High-dose 2X)
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
Dietary Supplement: Study Product B (Low-dose X)
Placebo product: 5g/sachet, containing the following active ingredients: * Maltodextrin * Pigment * Erythritol * Bitters * Essence of flavor
Dietary Supplement: Placebo
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Change of Serum Uric Acid Level
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
Time frame: baseline, and 12 weeks
Change of Serum Uric Acid Level
Change of Serum Uric Acid Level from baseline to 6 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days
Time frame: baseline, and 6 weeks
Fractional Excretion of Uric Acid (FEUA)
Fractional Excretion of Uric Acid (FEUA), defined as the percentage of urate filtered by glomeruli that is excreted in urine, normal range 7\~12%. A FEUA value less than 7% considered low, indicating decreased renal excretion of uric acid. A FEUA value above 12% is considered high, suggesting increased renal excretion of uric acid.
Time frame: baseline, 6 weeks, and 12 weeks
Plan to share: No
Start is estimated for Oct 2023; primary completion for Feb 2024, 4 months later.
Of 24 interventional studies with no phase under Hyperuricemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 34. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Amway (China) R&D Center