A clinical study to evaluate the safety and efficacy of cognitive enhancing function of of a white ginseng extract

A double-blind placebo-controlled study to evaluate the safety and efficacy of cognitive enhancing function of GEF as a white ginseng non-aqueous alcohol extract

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004636

Enrollment

Registered

2020-01-22

Start date

2018-10-25

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test food: Capsule containing 150mg of white ginseng (Ginseng) non-aqueous alcohol extract (GEF) powder and 250mg of excipients (dextrin, crystalline cellulose, caramel color, gar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult volunteers who subjectively complain of cognitive decline and whose age is between 50 and 85 2) K-MMSE score of 23 or more 3) No limitation of daily activities due to the dysfunction in cognition 4) Agreed to participate in the current study and signed to the Informed consent

Exclusion criteria

Exclusion criteria: (1) Those who are taking ginseng or health functional foods containing ginseng ingredients (2) Allergies or hypersensitivity to ginseng (3) Those who have clinically significant liver or kidney disease and whose ALT or AST or bilirubin is more than three times the upper limit of normal. (4) Those who have creatinine> 2.0mg / Dl (176.7µmol / L) or need dialysis (5) A person who has undergone surgery or the like that cannot interfere with food absorption or who cannot perform oral administration (6) Those who are being treated for major mental disorders such as mood swings and schizophrenia (7) Have been diagnosed with dementia in the hospital (8)Those who are illiterate (9) Those who have taken anti-dementia medications or administered drugs and health functional foods that can affect memory and cognitive function within 4 weeks of the human trial (Anti-dementia medications: donepezil, galantamime, rivastigmine, memantine Acetyl-L-carnitine, Choline Alfoscerate, Ginkgo biloba / Cognitive inhibitors: anticholinergics (eg, urination control) (10) alcohol or drug addicts (11) Those who are receiving other test drugs related to cognitive improvement (12) pregnant or expected, nursing mothers (13) Participants in other human trials or clinical trials within one month of the visit. (14) A person who deems it inappropriate for the researcher to participate.

Design outcomes

Primary

Measure	Time frame
Mini-mental status examination score	—

Secondary

Measure	Time frame
ADAS-cog score;stroop test score;DCE-MRI imaging parameters (K-trans, Vp);Beck Depression Inventory score;Clinical Dementia Rating scire	—

Countries

Korea, Republic of

Contacts

Public ContactWoo-Jin Lee

Seoul National University Hospital

Outcome results