NCT04167449已完成4 期
Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects. A Prospective, Randomized, Double Blind, Placebo-controlled, 3-armed Cross-over Study
EuroPharma, Inc.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
研究概览
简要总结
A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be capable of giving informed consent.
- •Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).
排除标准
- •Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded:
- •Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
- •Clinically relevant allergic symptoms.
- •Detection of alcohol at the time of initial examination (day SC) or on any study (positive alcohol test) or by case history.
- •Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
- •Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
- •Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
- •Smoking in the study center on study days A, B, C and D.
- •Participation in another clinical trial within the last 60 days.
- •Bad compliance.
- •Cancellation of informed consent.
结局指标
主要结局
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
时间窗: Four weeks
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: d2-test for attention (d2-Test).
次要结局
未报告次要终点
研究者
研究点 (2)
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