Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
NCT ID: NCT03439098
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-07-06
2016-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg/day
Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg/day
Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
Placebo
Placebo
Placebo
Placebo daily for 8 weeks
Interventions
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Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
Placebo
Placebo daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Global Deterioration Scale score (GDS) of 2
* High school or higher levels of education
* With informed consent
Exclusion Criteria
* Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV)
* Mini-mental status examination score of 25 or less
* Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
* Intelligence quotient less than 70
* Any history of head trauma involving loss of consciousness or seizure
* Contraindications to magnetic resonance imaging (MRI)
* Use of psychotropics in last 3 months
* Allergic adverse reactions to Fermented Codonopsis lanceolata
* Participation in other clinical trials during the study period that might affect the outcome of the present study
* Use of oral contraceptive medication
* Current pregnancy or breast-feeding
20 Years
65 Years
ALL
No
Sponsors
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Ewha Womans University
OTHER
Responsible Party
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In Kyoon Lyoo
Professor
Principal Investigators
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Inkyoon Lyoo, MD, PhD, MMS
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University
Locations
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Ewha Womans University
Seoul, , South Korea
Countries
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Other Identifiers
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EBI_CT_FCL
Identifier Type: -
Identifier Source: org_study_id
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