Status:
COMPLETED
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Lead Sponsor:
Ewha Womans University
Conditions:
Subjective Memory Complaints
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03439098
Start Date
July 6 2015
End Date
May 19 2016
Last Update
August 14 2019
Active Locations (1)
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1
Ewha Womans University
Seoul, South Korea, 03760