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

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.

Study Overview

• Status: Completed
• Conditions: Stress Relief
• Intervention / Treatment: Dietary supplement: Korean Red Ginseng; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo Capsule (1g/day) for 8 Weeks
Experimental: Korean Red Ginseng	Dietary supplement: Korean Red Ginseng; Korean Red Ginseng Capsule (1g/day) for 8 Weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 26, 2012
• First Submitted That Met QC Criteria: February 26, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 23, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KG2010