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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542905

Contacts
Contact: Junghyun H Lee, MD, MS +82-10-3453-1744 leejunghyun1@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeong-Hwa Hong, MD    +82-740-8096    jhhong@snu.ac.kr   
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
  More Information

No publications provided

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
Study First Received: February 26, 2012
Last Updated: March 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on August 18, 2014