Stress Relief Effect of Korean Red Ginseng

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of Korean Red Ginseng on Stress Relief and Cognitive and Mental Function Enhancement Using Neuroimaging: Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Conditions
-----------------
Stress Relief

Intervention / Treatment
-----------------
* Dietary Supplement: Korean Red Ginseng
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 18 65 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Red Ginseng<br> | Dietary Supplement: Korean Red Ginseng<br>* Korean Red Ginseng Capsule (1g/day) for 8 Weeks<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo Capsule (1g/day) for 8 Weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Stress Scores at 8 Weeks |  | Baseline and 8 Weeks | 
| Change from Baseline in Stress Scores at 4 Weeks |  | Baseline and 4 Weeks | 
| Change from Baseline in Stress Scores at 1 Week |  | Baseline and 1 Week | 
| Change from Baseline in Neurocognitive Function at 8 Weeks |  | Baseline and 8 Weeks | 
| Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks |  | Baseline and 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Scores at 8 Weeks |  | Baseline and 8 Weeks | 
| Change in Fatigue Scores at 4 Weeks |  | Baseline and 4 Weeks | 
| 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 | 
| 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 1 | 
| Number of Participants Who Experienced Adverse Events |  | Week 4 | 
| Number of Participants Who Experienced Adverse Events |  | Week 8 |