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Clinical Trial for the Evaluation of the Efficacy and Safety of AGE on Reducing Serum Uric Acid

A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of AGE on Reducing Serum Uric Acid

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005388
Enrollment
56
Registered
2020-09-09
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive test group or Placebo. Subjects will take 2 tablets twice a day for 8weeks

Sponsors

H Plus Yangji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects between 20 ~75 years of age 2) Uric acid of visit 1,2 is placed on 7.0 mg/dL~9.0 mg/dL 3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.

Exclusion criteria

Exclusion criteria: 1) Those who have been diagnosed with gout (based on ACR / EULAR: 2015). 2) Those who have experienced gouty seizure at least once. 3) Subjects who are receving treatment with severe cerebrovascular disease or immune, respiratory sytem disease or disease of liver, kidney and urinary tract, nervous system, or mental illness or malignant tumor. (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) 4) Those who are hospitalized, medicated with Alcohol abuse and dependence 5) Those with history of urinary tract absences 6) Those who have taken uric acid inhibitors (allopurinol, phenytoestat etc.) 7) Those taking thiazide diuretics within 4 weeks of the start of the study 8) Those who have taken functional foods, antacids, vitamin K antagonists, oral contraceptives, antifungal agents, and large amounts of grapefruit juice that affect the absorption, metabolism, excretion, and uric acid levels of this testing food within 1 week of Visit 3 (Baseline) 9) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization) 10) Unregulated diabetic patients(fasting blood sugar over 180 mg/dL ) 11) TSH Less than 0.1 uIU / ml, or 10 uIU / ml or more 12) AST (GOT) or ALT (GPT) is more than three times the normal range of the laboratory. 13) Creatinine is more than twice the normal range of the laboratory. 14) Those planning to become pregnant during pregnancy, during lactation, or within this cinical trail. 15) Those who have participated in other clinical studies within 3 months of the start of the human body test or plan to participate in other clinical studies 16) The person who is deemed inappropriate by this test

Design outcomes

Secondary

MeasureTime frame
Proportion of subjects with a serum uric acid concentration reduced over 10%.;CRP(C-reactive protein) concentraton in the blood

Primary

MeasureTime frame
serum uric acid concentration

Countries

Korea, Republic of

Contacts

Public Contactseung hyun Kang

H Plus Yangji Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026