Effects of Korean Red Ginseng on Stress Relief and Cognitive and Mental Function Enhancement Using Neuroimaging: Double-Blind, Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change from Baseline in Stress Scores at 8 Weeks
研究概览
简要总结
The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red Ginseng and examine changes in brain structure, function and metabolites. A total of 60 healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group or placebo group. Individuals will be examined through clinical assessment, neuropsychological function tests and neuroimaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages between 18~65
排除标准
- •Current or past medical history, medical illnesses that are detected during clinical and physical evaluations
- •Current Axis 1 diagnosis or past history of schizophrenia, bipolar, or psychotic disorders assessed by SCID-IV
- •Current diagnosis of substance abuse assessed by SCID-IV
- •Taking or have taken psychiatric medication in the past 2 months
- •Head trauma accompanied by loss of consciousness or seizure
- •IQ 80 or below
- •Planning pregnancy, currently pregnant, or breastfeeding
- •Claustrophobia or other fMRI incompatible factors such as pace makers
- •Taking drugs, including over the counter drugs
结局指标
主要结局
Change from Baseline in Stress Scores at 8 Weeks
时间窗: Baseline and 8 Weeks
Change from Baseline in Stress Scores at 4 Weeks
时间窗: Baseline and 4 Weeks
Change from Baseline in Stress Scores at 1 Week
时间窗: Baseline and 1 Week
Change from Baseline in Neurocognitive Function at 8 Weeks
时间窗: Baseline and 8 Weeks
Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks
时间窗: Baseline and 8 Weeks
次要结局
- Change in Fatigue Scores at 8 Weeks(Baseline and 8 Weeks)
- Change in Fatigue Scores at 4 Weeks(Baseline and 4 Weeks)
- Change in Depressive Scores at 1 Week(Baseline and 1 Week)
- Change in Anxiety Scores at 8 Weeks(Baseline and 8 Weeks)
- Change in Anxiety Scores at 4 Weeks(Baseline and 4 Weeks)
- Change in Anxiety Scores at 1 Week(Baseline and 1 Week)
- Number of Participants Who Experienced Adverse Events(Week 8)
- Change in Fatigue Scores at 1 Week(Baseline and 1 Week)
- Change in Depressive Scores at 8 Weeks(Baseline and 8 Weeks)
- Change in Depressive Scores at 4 Weeks(Baseline and 4 Weeks)
研究者
In Kyoon Lyoo, MD, PhD, MMS
Professor
Seoul National University Hospital