KCT0004636已完成未知
A double-blind placebo-controlled study to evaluate the safety and efficacy of cognitive enhancing function of GEF as a white ginseng non-aqueous alcohol extract
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 76
研究概览
简要总结
There was no statistically significant difference in the primary or the secondary outcome parameters between the test and the control groups. There was no development of a medically significant adverse event in the test group. We concluded that there was no evidence of a significant cognitive enhancing effect of GEF, neither of a safety issue.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Adult volunteers who subjectively complain of cognitive decline and whose age is between 50 and 85
- •2) K-MMSE score of 23 or more
- •3) No limitation of daily activities due to the dysfunction in cognition
- •4) Agreed to participate in the current study and signed to the Informed consent
排除标准
- •(1) Those who are taking ginseng or health functional foods containing ginseng ingredients
- •(2) Allergies or hypersensitivity to ginseng
- •(3) Those who have clinically significant liver or kidney disease and whose ALT or AST or bilirubin is more than three times the upper limit of normal.
- •(4) Those who have creatinine> 2.0mg / Dl (176.7µmol / L) or need dialysis
- •(5) A person who has undergone surgery or the like that cannot interfere with food absorption or who cannot perform oral administration
- •(6) Those who are being treated for major mental disorders such as mood swings and schizophrenia
- •(7) Have been diagnosed with dementia in the hospital
- •(8)Those who are illiterate
- •(9) Those who have taken anti-dementia medications or administered drugs and health functional foods that can affect memory and cognitive function within 4 weeks of the human trial (Anti-dementia medications: donepezil, galantamime, rivastigmine, memantine Acetyl-L-carnitine, Choline Alfoscerate, Ginkgo biloba / Cognitive inhibitors: anticholinergics (eg, urination control)
- •(10) alcohol or drug addicts
- •(11) Those who are receiving other test drugs related to cognitive improvement
- •(12) pregnant or expected, nursing mothers
- •(13) Participants in other human trials or clinical trials within one month of the visit.
- •(14) A person who deems it inappropriate for the researcher to participate.
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