Stress Relief Effect of Korean Red Ginseng | NCT01542905

Studies
Stress Relief Effect of Korean Red Ginseng

NCT01542905

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

51Actual

Phase

Not Applicable

Conditions

Stress Relief

Interventions

Korean Red Ginseng
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Feb 26, 2012

First Submission Date that Met QC Criteria

Feb 26, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2015

Last Update Posted Date

May 27, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Korean Red Ginseng	Experimental		Dietary Supplement: Korean Red Ginseng
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Korean Red Ginseng	Dietary Supplement	Korean Red Ginseng Capsule (1g/day) for 8 Weeks	Korean Red Ginseng

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Change in Fatigue Scores at 8 Weeks		Baseline and 8 Weeks
Change in Fatigue Scores at 4 Weeks		Baseline and 4 Weeks
Change in Fatigue Scores at 1 Week

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In Kyoon Lyoo, MD, PhD, MMS	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C000713447	Asian ginseng

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided