Stress Relief
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKorean Red Ginseng
Korean Red Ginseng Capsule (1g/day) for 8 Weeks
OTHERPlacebo
Placebo Capsule (1g/day) for 8 Weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in Depressive Scores at 1 Week | Baseline and 1 Week |
| Change in Anxiety Scores at 8 Weeks | Baseline and 8 Weeks |
| Change in Fatigue Scores at 8 Weeks | Baseline and 8 Weeks |
| Change in Anxiety Scores at 1 Week | Baseline and 1 Week |
| Number of Participants Who Experienced Adverse Events | Week 1 |
| Change in Anxiety Scores at 4 Weeks | Baseline and 4 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 |
Countries
South Korea
Outcome results
None listed