The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
NCT ID: NCT06084585
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2023-10-23
2024-03-15
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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
Study Product A (High-dose 2X)
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Study Product B (Low-dose X)
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
Study Product B (Low-dose X)
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Placebo
Placebo product: 5g/sachet, containing the following active ingredients:
* Maltodextrin
* Pigment
* Erythritol
* Bitters
* Essence of flavor
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
Interventions
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Study Product A (High-dose 2X)
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Study Product B (Low-dose X)
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Amway (China) R&D Center
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Cao, MD
Role: PRINCIPAL_INVESTIGATOR
Jinhua Wenrong Hospital
Locations
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Charlie Zhang
Jinhua, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors. Nat Rev Rheumatol. 2020 Jul;16(7):380-390. doi: 10.1038/s41584-020-0441-1. Epub 2020 Jun 15.
Choi HK, Mount DB, Reginato AM; American College of Physicians; American Physiological Society. Pathogenesis of gout. Ann Intern Med. 2005 Oct 4;143(7):499-516. doi: 10.7326/0003-4819-143-7-200510040-00009. No abstract available.
Zhang M, Zhu X, Wu J, Huang Z, Zhao Z, Zhang X, Xue Y, Wan W, Li C, Zhang W, Wang L, Zhou M, Zou H, Wang L. Prevalence of Hyperuricemia Among Chinese Adults: Findings From Two Nationally Representative Cross-Sectional Surveys in 2015-16 and 2018-19. Front Immunol. 2022 Feb 7;12:791983. doi: 10.3389/fimmu.2021.791983. eCollection 2021.
Li L, Zhang Y, Zeng C. Update on the epidemiology, genetics, and therapeutic options of hyperuricemia. Am J Transl Res. 2020 Jul 15;12(7):3167-3181. eCollection 2020.
Liu N, Wang Y, Yang M, Bian W, Zeng L, Yin S, Xiong Z, Hu Y, Wang S, Meng B, Sun J, Yang X. New Rice-Derived Short Peptide Potently Alleviated Hyperuricemia Induced by Potassium Oxonate in Rats. J Agric Food Chem. 2019 Jan 9;67(1):220-228. doi: 10.1021/acs.jafc.8b05879. Epub 2018 Dec 28.
Gliozzi M, Malara N, Muscoli S, Mollace V. The treatment of hyperuricemia. Int J Cardiol. 2016 Jun 15;213:23-7. doi: 10.1016/j.ijcard.2015.08.087. Epub 2015 Aug 8.
Jiang LL, Gong X, Ji MY, Wang CC, Wang JH, Li MH. Bioactive Compounds from Plant-Based Functional Foods: A Promising Choice for the Prevention and Management of Hyperuricemia. Foods. 2020 Jul 23;9(8):973. doi: 10.3390/foods9080973.
Yang B, Xin M, Liang S, Xu X, Cai T, Dong L, Wang C, Wang M, Cui Y, Song X, Sun J, Sun W. New insight into the management of renal excretion and hyperuricemia: Potential therapeutic strategies with natural bioactive compounds. Front Pharmacol. 2022 Nov 22;13:1026246. doi: 10.3389/fphar.2022.1026246. eCollection 2022.
Li S, Li L, Yan H, Jiang X, Hu W, Han N, Wang D. Anti-gouty arthritis and anti-hyperuricemia properties of celery seed extracts in rodent models. Mol Med Rep. 2019 Nov;20(5):4623-4633. doi: 10.3892/mmr.2019.10708. Epub 2019 Sep 26.
Wang Y, Lin Z, Zhang B, Nie A, Bian M. Cichorium intybus L. promotes intestinal uric acid excretion by modulating ABCG2 in experimental hyperuricemia. Nutr Metab (Lond). 2017 Jun 13;14:38. doi: 10.1186/s12986-017-0190-6. eCollection 2017.
Wang Y, Lin Z, Zhang B, Jiang Z, Guo F, Yang T. Cichorium intybus L. Extract Suppresses Experimental Gout by Inhibiting the NF-kappaB and NLRP3 Signaling Pathways. Int J Mol Sci. 2019 Oct 4;20(19):4921. doi: 10.3390/ijms20194921.
Wang MX, Liu YL, Yang Y, Zhang DM, Kong LD. Nuciferine restores potassium oxonate-induced hyperuricemia and kidney inflammation in mice. Eur J Pharmacol. 2015 Jan 15;747:59-70. doi: 10.1016/j.ejphar.2014.11.035. Epub 2014 Dec 8.
Cheng-Yuan W, Jian-Gang D. Research progress on the prevention and treatment of hyperuricemia by medicinal and edible plants and its bioactive components. Front Nutr. 2023 Jun 12;10:1186161. doi: 10.3389/fnut.2023.1186161. eCollection 2023.
Li R, Tan Y, Li Y, Zhu X, Tang X, Zhang L, Chen J. Effects of Tart Cherry Powder on Serum Uric Acid in Hyperuricemia Rat Model. Evid Based Complement Alternat Med. 2020 Jul 22;2020:1454305. doi: 10.1155/2020/1454305. eCollection 2020.
Chen PE, Liu CY, Chien WH, Chien CW, Tung TH. Effectiveness of Cherries in Reducing Uric Acid and Gout: A Systematic Review. Evid Based Complement Alternat Med. 2019 Dec 4;2019:9896757. doi: 10.1155/2019/9896757. eCollection 2019.
Other Identifiers
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22-RB-07-AY-001
Identifier Type: -
Identifier Source: org_study_id
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