Stress Relief Effect of Korean Red Ginseng

Not Applicable

Completed

• Conditions: Stress Relief
• Interventions: Dietary Supplement: Korean Red Ginseng; Other: Placebo

• Registration Number: NCT01542905
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-02-26
• Study First Submitted QC: 2012-02-26
• Study First Posted: 2012-03-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-23
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Ages between 18~65

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korean Red Ginseng	Korean Red Ginseng	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Fatigue Scores at 8 Weeks	Baseline and 8 Weeks
Change in Fatigue 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 8
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of