Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions

NCT ID: NCT03439098

Last Updated: 2019-08-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-06

Study Completion Date

2016-05-19

Brief Summary

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The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.

Detailed Description

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Conditions

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Subjective Memory Complaints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fermented Codonopsis lanceolata 525mg

Fermented Codonopsis lanceolata 525mg/day

Group Type EXPERIMENTAL

Fermented Codonopsis lanceolata 525mg

Intervention Type DIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Fermented Codonopsis lanceolata 1050mg

Fermented Codonopsis lanceolata 1050mg/day

Group Type EXPERIMENTAL

Fermented Codonopsis lanceolata 1050mg

Intervention Type DIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo daily for 8 weeks

Interventions

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Fermented Codonopsis lanceolata 525mg

Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 1050mg

Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 65 years old
* Global Deterioration Scale score (GDS) of 2
* High school or higher levels of education
* With informed consent

Exclusion Criteria

* Evidence of neurologic or medical conditions
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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In Kyoon Lyoo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

Other Identifiers

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EBI_CT_FCL

Identifier Type: -

Identifier Source: org_study_id

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