KCT0000339招募中未知
A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of poly-gamma-glutamic acid(0.15g/day) on reducing serum triglycerides of male and female adults(200mg/dl<= serum triglycerides <500mg/dl)
Inje University Seoul Paik Hospital0 个研究点目标入组 80 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
- 80
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
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Male and female subjects of 200mg/dl -500mg/dl in serum triglycerides 2) Male and female subjects between 19-65 years old
- •3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
排除标准
- •1. Subjects who took a drug(total-cholesterol treatment) within 3 months
- •2. Subjects with hyperlipidemia who need a drug treatment
- •3. Subjects with cardiovascular disorder
- •4. Subjects who use of antiobestic drug
- •5. Subjects who use of beta blocker or hydragogue
- •6. Subjects with diabetes (fasting blood glucose 126= or random blood glucose =200, and also use of hypoglycemic agent or insulin)
- •7. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10uU/ml)
- •8. Subjects with serum AST/ALT = 3 times the upper limit of normal
- •9. Subjects with severe gastrointestinal symptom(heartburn, indigestion)
- •10. Subjects who drinks alcohol 4 times per a week
- •11. Subjects with disease of gallbladder, gastrointestinal, gout, porphyria
- •12. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction )
- •13. Subjects with malnutrition
- •14. Woman who are pregnant or lactating
- •15. Subjects who have a plan to participate in other clinical trial
- •16. Subjects who took part in other clinical trial within 3 months
- •17. Subjects which in the opinion investigator could affect preclude evauation of response
研究者
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