A clinical study on the safety and efficacy of white ginseng extract in cognitive decline

A double-blind placebo-controlled, dose dependent pilot 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

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006479

Enrollment

Registered

2021-08-20

Start date

2020-02-10

Completion date

Unknown

Last updated

2021-08-30

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 300mg(or 600mg) of white ginseng (Ginseng) non-aqueous alcohol extract (GEF) powder and 250mg of excipients (dextrin, crystalline cellulose, caramel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those aged 50 to 85 years of age who complain of subjective memory impairment 2) Those with a K-MMSE score of 23 or higher 3) Those who do not interfere with daily life due to cognitive decline 4) Those who consented to participate in the clinical trial before the start of this study and signed an informed consent

Exclusion criteria

Exclusion criteria: (1) Those who are consuming ginseng or health functional food containing ginseng ingredients (2) Those with allergies or hypersensitivity to ginseng (3) Those with clinically significant liver disease or renal disease, with ALT, AST, or bilirubin at least 3 times the upper limit of normal (4) Those who have blood creatinine>2.0mg/Dl (176.7µmol/L) or need kidney dialysis (5) Those who have undergone surgery that may interfere with food absorption or are unable to administer oral administration (6) Those receiving treatment for major psychiatric disorders such as bipolar disorder and schizophrenia (7) Those diagnosed with dementia at the hospital (8) The illiterate (9) Those who have taken anti-dementia drugs within 4 weeks of the start of the human application test, or have administered drugs and health functional foods that may affect memory and cognitive function (10) Alcoholic or drug addicts (11) Those receiving other test drugs related to cognitive function improvement (12) Pregnant or prospective pregnant women (13) Those who participated in other human application tests or clinical trials within one month of the visit (14) Those who are judged to be inappropriate for the researcher to participate

Design outcomes

Primary

Measure	Time frame
Mini-mental status examination score;adverse events, adverse drug reaction, serious AE/ADR, unexpected ADR	—

Secondary

Measure	Time frame
ADAS-cog score;stroop test score ;Beck Depression Inventory score;Clinical Dementia Rating score	—

Countries

Korea, Republic of

Contacts

Public ContactDae-seop Shin

Seoul National University Hospital

shindsd2@naver.com+82-2-2072-2193

Outcome results