Stress Relief Effect of Korean Red Ginseng

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01542905
First received: February 26, 2012
Last updated: March 1, 2012
Last verified: March 2012

February 26, 2012
March 1, 2012
July 2011
July 2012   (final data collection date for primary outcome measure)
  • Change from Baseline in Stress Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Stress Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Stress Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Change from Baseline in Neurocognitive Function at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01542905 on ClinicalTrials.gov Archive Site
  • Change in Fatigue Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Fatigue Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Fatigue Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Experienced Adverse Events [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • Change in Fatigue Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Fatigue Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Fatigue Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Depressive Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 8 Weeks [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 4 Weeks [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Scores at 1 Week [ Time Frame: Baseline and 1 Week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stress Relief
  • Dietary Supplement: Korean Red Ginseng
    Korean Red Ginseng Capsule (1g/day) for 8 Weeks
  • Other: Placebo
    Placebo Capsule (1g/day) for 8 Weeks
  • Experimental: Korean Red Ginseng
    Intervention: Dietary Supplement: Korean Red Ginseng
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Junghyun H Lee, MD, MS +82-10-3453-1744 leejunghyun1@gmail.com
Korea, Republic of
 
NCT01542905
KG2010
Yes
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
Seoul National University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP