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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Product A (High-dose 2X) | Active Comparator | Amway uric acid lowering product: 5g/sachet, containing the following active ingredients:
|
|
| Study Product B (Low-dose X) | Active Comparator | Amway uric acid lowering product: 5g/sachet, containing the following active ingredients:
|
|
| Placebo | Placebo Comparator | Placebo product: 5g/sachet, containing the following active ingredients:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Product A (High-dose 2X) | Dietary Supplement | participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, and 6 weeks |
| Fractional Excretion of Uric Acid (FEUA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlie Zhang, MD | Contact | +8613901981272 | charlie.zhang@raisonbiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Cao, MD | Jinhua Wenrong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlie Zhang | Recruiting | Jinhua | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32541923 | Background | 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. | |
| 16204163 | Background | 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. |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Study Product B (Low-dose X) | Dietary Supplement | 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 | Dietary Supplement | participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months |
|
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. |
| baseline, 6 weeks, and 12 weeks |
| 35197964 | Background | 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. |
| 32774692 | Background | 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. |
| 30562028 | Background | 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. |
| 26320372 | Background | 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. |
| 32717824 | Background | 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. |
| 36483739 | Background | 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. |
| 31702020 | Background | 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. |
| 28630638 | Background | 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. |
| 31590257 | Background | 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. |
| 25499818 | Background | 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. |
| 37377486 | Background | 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. |
| 32774405 | Background | 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. |
| 31885677 | Background | 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. |