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HyperuricemiaNCT06084585

The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

A study testing Study Product A (High-dose 2X) and Study Product B (Low-dose X) in people with Hyperuricemia, run by Amway (China) R&D Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hyperuricemia
What is being tested?
Study Product A (High-dose 2X) and Study Product B (Low-dose X)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
23 Oct 2023to 15 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Charlie Zhang

    Jinhua, Zhejiang

    Charlie BC Zhang, MD, +8613901981272, charlie.zhang@raisonbiotech.com

    Recruiting

Other trials in China

About this study

Official title: A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

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
Read more

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.

Conditions
Hyperuricemia
Being tested
Study Product A (High-dose 2X), Study Product B (Low-dose X), Placebo
Keywords
Uric Acid, Amway
Medical subject headings
Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

  • PlaceboDietary 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

Study groups in NCT06084585
Study groupRoleWhat they receive
Study Product A (High-dose 2X)Active comparatorAmway 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
Receives: Dietary Supplement: Study Product A (High-dose 2X)
Study Product B (Low-dose X)Active comparatorAmway 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
Receives: Dietary Supplement: Study Product B (Low-dose X)
PlaceboPlacebo comparatorPlacebo product: 5g/sachet, containing the following active ingredients: * Maltodextrin * Pigment * Erythritol * Bitters * Essence of flavor
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, and 12 weeks

Secondary outcomes (2)
  1. 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

    Measured: baseline, and 6 weeks

  2. 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.

    Measured: baseline, 6 weeks, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start23 Oct 2023 (estimated)
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion15 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084585
Sponsor's protocol ID
22-RB-07-AY-001
Status last verified
Oct 2023
First submitted
10 Oct 2023
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32541923
  • 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.

    PubMed 16204163
  • 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.

    PubMed 35197964
  • 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.

    PubMed 32774692
  • 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.

    PubMed 30562028
  • 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.

    PubMed 26320372
  • 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.

    PubMed 32717824
  • 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.

    PubMed 36483739
  • 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.

    PubMed 31702020
  • 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.

    PubMed 28630638
  • 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.

    PubMed 31590257
  • 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.

    PubMed 25499818
  • 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.

    PubMed 37377486
  • 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.

    PubMed 32774405
  • 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.

    PubMed 31885677

Questions about this trial

What is this clinical trial studying?

A study testing Study Product A (High-dose 2X) and Study Product B (Low-dose X) in people with Hyperuricemia, run by Amway (China) R&D Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Charlie Zhang, MD (+8613901981272, charlie.zhang@raisonbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Serum Uric Acid Level (time frame: baseline, and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06084585, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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