Stress ReliefNCT01542905
Stress Relief Effect of Korean Red Ginseng
A study testing Korean Red Ginseng in people with Stress Relief, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Relief
- What is being tested?
- Korean Red Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 18~65
Who cannot join
- 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
Show all 9Show fewer
- Planning pregnancy, currently pregnant, or breastfeeding
- Claustrophobia or other fMRI incompatible factors such as pace makers
- Taking drugs, including over the counter drugs
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Stress Relief
- Being tested
- Korean Red Ginseng, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
Korean Red Ginseng Capsule (1g/day) for 8 Weeks
PlaceboOther
Placebo Capsule (1g/day) for 8 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng | Experimental | Not described Receives: Dietary Supplement: Korean Red Ginseng |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Stress Scores at 8 Weeks
Measured: Baseline and 8 Weeks
Change from Baseline in Stress Scores at 4 Weeks
Measured: Baseline and 4 Weeks
Change from Baseline in Stress Scores at 1 Week
Measured: Baseline and 1 Week
Change from Baseline in Neurocognitive Function at 8 Weeks
Measured: Baseline and 8 Weeks
Change from Baseline in Brain Function, Chemistry, and Structure Measured Using Magnetic Resonance Imaging at 8 Weeks
Measured: Baseline and 8 Weeks
Secondary outcomes (12)
Change in Fatigue Scores at 8 Weeks
Measured: Baseline and 8 Weeks
Change in Fatigue Scores at 4 Weeks
Measured: Baseline and 4 Weeks
Change in Fatigue Scores at 1 Week
Measured: Baseline and 1 Week
Change in Depressive Scores at 8 Weeks
Measured: Baseline and 8 Weeks
Change in Depressive Scores at 4 Weeks
Measured: Baseline and 4 Weeks
Change in Depressive Scores at 1 Week
Measured: Baseline and 1 Week
Change in Anxiety Scores at 8 Weeks
Measured: Baseline and 8 Weeks
Change in Anxiety Scores at 4 Weeks
Measured: Baseline and 4 Weeks
Change in Anxiety Scores at 1 Week
Measured: Baseline and 1 Week
Number of Participants Who Experienced Adverse Events
Measured: Week 1
Number of Participants Who Experienced Adverse Events
Measured: Week 4
Number of Participants Who Experienced Adverse Events
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReliefStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542905
- Sponsor's protocol ID
- KG2010
- Status last verified
- May 2015
- First submitted
- 26 Feb 2012
- Last updated
- 27 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01542905
- Acronym / sponsor ID
- KG2010
- Conditions
- Stress Relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng | Experimental | Dietary Supplement: Korean Red Ginseng |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages between 18~65
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red GinsengKorean Red Ginseng Capsule (1g/day) for 8 Weeks | Dietary supplement | Korean Red Ginseng |
| PlaceboPlacebo Capsule (1g/day) for 8 Weeks | Other | Placebo |
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean Red Ginseng in people with Stress Relief, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Stress Scores at 8 Weeks (time frame: Baseline and 8 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.