Stress Relief Effect of Korean Red Ginseng
Effects of Korean Red Ginseng on Stress Relief and Cognitive and Mental Function Enhancement Using Neuroimaging: Double-Blind, Randomized, Placebo-Controlled Clinical Trial
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedMay 27, 2015
May 1, 2015
11 months
February 26, 2012
May 23, 2015
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Korean Red Ginseng
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Korean Red Ginseng Capsule (1g/day) for 8 Weeks
Eligibility Criteria
You may qualify if:
- Ages between 18\~65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
In Kyoon Lyoo, MD, PhD, MMS
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 26, 2012
First Posted
March 2, 2012
Study Start
May 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 27, 2015
Record last verified: 2015-05