Clinical trial NCT01542905: Stress Relief Effect of Korean Red Ginseng
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Relief
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Stress Scores at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Change from Baseline in Stress Scores at 4 Weeks
timeFrame: Baseline and 4 Weeks
measure: Change from Baseline in Stress Scores at 1 Week
timeFrame: Baseline and 1 Week
measure: Change from Baseline in Neurocognitive Function at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Change in Fatigue Scores at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Change in Fatigue Scores at 4 Weeks
timeFrame: Baseline and 4 Weeks
measure: Change in Fatigue Scores at 1 Week
timeFrame: Baseline and 1 Week
measure: Change in Depressive Scores at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Change in Depressive Scores at 4 Weeks
timeFrame: Baseline and 4 Weeks
measure: Change in Depressive Scores at 1 Week
timeFrame: Baseline and 1 Week
measure: Change in Anxiety Scores at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Change in Anxiety Scores at 4 Weeks
timeFrame: Baseline and 4 Weeks
measure: Change in Anxiety Scores at 1 Week
timeFrame: Baseline and 1 Week
measure: Number of Participants Who Experienced Adverse Events
timeFrame: Week 1
measure: Number of Participants Who Experienced Adverse Events
timeFrame: Week 4
measure: Number of Participants Who Experienced Adverse Events
timeFrame: Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: