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Stress Relief Effect of Korean Red Ginseng

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542905
First Posted: March 2, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
  Purpose
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.

Condition Intervention
Stress Relief Dietary Supplement: Korean Red Ginseng Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital:

Primary Outcome Measures:
  • Change from Baseline in Stress Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change from Baseline in Stress Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ]
  • Change from Baseline in Stress Scores at 1 Week [ Time Frame: Baseline and 1 Week ]
  • Change from Baseline in Neurocognitive Function at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]

Secondary Outcome Measures:
  • Change in Fatigue Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change in Fatigue Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ]
  • Change in Fatigue Scores at 1 Week [ Time Frame: Baseline and 1 Week ]
  • Change in Depressive Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change in Depressive Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ]
  • Change in Depressive Scores at 1 Week [ Time Frame: Baseline and 1 Week ]
  • Change in Anxiety Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change in Anxiety Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ]
  • Change in Anxiety Scores at 1 Week [ Time Frame: Baseline and 1 Week ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 1 ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 4 ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 8 ]

Enrollment: 51
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Korean Red Ginseng Dietary Supplement: Korean Red Ginseng
Korean Red Ginseng Capsule (1g/day) for 8 Weeks
Placebo Comparator: Placebo Other: Placebo
Placebo Capsule (1g/day) for 8 Weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542905


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
  More Information

Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01542905     History of Changes
Other Study ID Numbers: KG2010
First Submitted: February 26, 2012
First Posted: March 2, 2012
Last Update Posted: May 27, 2015
Last Verified: May 2015