Clinical Trial for the Evaluation of the Efficacy and Safety of AGE on Reducing Serum Uric Acid
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005388
- Lead Sponsor
- H Plus Yangji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum uric acid concentration
- Secondary Outcome Measures
Name Time Method Proportion of subjects with a serum uric acid concentration reduced <br>over 10%.;CRP(C-reactive protein) concentraton in the blood