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

Ewha Womans University

Status: Completed

Conditions: Subjective Memory Complaints

Treatments: Dietary Supplement: Fermented Codonopsis lanceolata 1050mg; Dietary Supplement: Placebo; Dietary Supplement: Fermented Codonopsis lanceolata 525mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03439098

EBI_CT_FCL

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Fermented Codonopsis lanceolata 525mg

Experimental group

Description:

Fermented Codonopsis lanceolata 525mg/day

Treatment:

Dietary Supplement: Fermented Codonopsis lanceolata 525mg

Fermented Codonopsis lanceolata 1050mg

Experimental group

Description:

Fermented Codonopsis lanceolata 1050mg/day

Treatment:

Dietary Supplement: Fermented Codonopsis lanceolata 1050mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo