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OpenTrials
Completed

NCT Number: NCT01542905

Stress Relief Effect of Korean Red Ginseng

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.

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Key information

Conditions

Stress Relief

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

Korean Red Ginseng Capsule (1g/day) for 8 Weeks

Placebo

Other

Placebo Capsule (1g/day) for 8 Weeks

Primary outcomes

  1. Change from Baseline in Stress Scores at 8 Weeks

    Time frame: Baseline and 8 Weeks

  2. Change from Baseline in Stress Scores at 4 Weeks

    Time frame: Baseline and 4 Weeks

  3. Change from Baseline in Stress Scores at 1 Week

    Time frame: Baseline and 1 Week

  4. Change from Baseline in Neurocognitive Function at 8 Weeks

    Time frame: Baseline and 8 Weeks

  5. Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks

    Time frame: Baseline and 8 Weeks

Secondary outcomes

  1. Change in Fatigue Scores at 8 Weeks

    Time frame: Baseline and 8 Weeks

  2. Change in Fatigue Scores at 4 Weeks

    Time frame: Baseline and 4 Weeks

  3. Change in Fatigue Scores at 1 Week

    Time frame: Baseline and 1 Week

  4. Change in Depressive Scores at 8 Weeks

    Time frame: Baseline and 8 Weeks

  5. Change in Depressive Scores at 4 Weeks

    Time frame: Baseline and 4 Weeks

  6. Change in Depressive Scores at 1 Week

    Time frame: Baseline and 1 Week

  7. Change in Anxiety Scores at 8 Weeks

    Time frame: Baseline and 8 Weeks

  8. Change in Anxiety Scores at 4 Weeks

    Time frame: Baseline and 4 Weeks

  9. Change in Anxiety Scores at 1 Week

    Time frame: Baseline and 1 Week

  10. Number of Participants Who Experienced Adverse Events

    Time frame: Week 1

  11. Number of Participants Who Experienced Adverse Events

    Time frame: Week 4

  12. Number of Participants Who Experienced Adverse Events

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Korean Red Ginseng on Stress Relief and Cognitive and Mental Function Enhancement Using Neuroimaging: Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2012
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.