KCT0003074招募中未知
Effect of Ginseng Berry extract on the Safety and Memory Improvement ; A Randomized, Double-blind, Placebo-Controlled Clinical Trial
Korea Genetic Pharm0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- 45(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. Males and females 45 =age = 65
- •2. Those with elementary school or higher education
- •3. Subjects whose MQ score in Rey-Kim memory test is 70 or more, but less than 120.
- •4. Subjects who after listening carefully and fully understanding this clinical trial, has decided to participate voluntarily and has agreed in writing to observe the cautions.
- •5. Subjects who are possible to follow up during the trial period.
- •6. Subjects whose depression or anxiety subscale score in HADS is less than 8.
- •7. Subjects who doesn’t meet the exclusion criteria
排除标准
- •1. Subjects with physical diseases which can affect memory such as neurodegenerative diseases like dementisa, Parkinson disease, traumatic brain injury, stroke.
- •2. Subjects who have taken any medicines or dietary supplements which can affect memory within 4 weeks.
- •3. Subjects who have allergic reaction or hypersensitive reaction to experimental supplement.
- •4. Subjects who have hepatoma, liver cirrhosis, chronic renal failure, congestive heart failure.
- •5. Subjects who have been taking antihistaminic agent, nonsteroidal antiinflammatory drug, steroid, antibiotics, decongestant.
- •6. Subjects who have been taking any medicine to treat hyperthyroidism or hypothyroidism within 1 year.(Subjects who investigators decided to be possible to participate to this trial can be involved.)
- •7. Subjects who have severe migraine, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina pectoris, or PTCA within 1 year.
- •8. Subjects who have mental disorders like depression, anxiety disorders, or been taking any antidepressants, antipsychotics agents.
- •9. Subjects who have uncontrolled diabetes mellitus. (FBT = 80mg/dL or Subjects who started new hypoglycemic agents withing the last 3 months)
- •10. Subjects who have history of drug or alcohol dependency or abuse.
- •11. ALT(Alanine transaminase) or AST(Aspartate transaminase) > 2.5 times compared to the normal upper limit in research institute.
- •12. Creatinine > 2.5 times compared to the normal upper limit in research institute.
- •13. Subjects who participated in another clinical study in the last 30 days or plan to participate in another clinical study.
- •14. Subjects who are pregnancy, breast feeding, or females of childbearing potential who are not practicing acceptable pregnancy prevention methods.
- •15. Subjects who are institutionalized in group facilities like social welfare organs.
- •16. Subjects who have difficulty of communication or writing due to visual, auditory, physical impairment.
- •17. Subjects who are not appropriate by investigator’s decision.
研究者
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