KCT0005388招募中未知
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
H Plus Yangji Hospital0 个研究点目标入组 56 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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