A clinical study to evaluate the safety and efficacy of cognitive enhancing function of of a white ginseng extract
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004636
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
There was no statistically significant difference in the primary or the secondary outcome parameters between the test and the control groups. There was no development of a medically significant adverse event in the test group. We concluded that there was no evidence of a significant cognitive enhancing effect of GEF, neither of a safety issue.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 76
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
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mini-mental status examination score
- Secondary Outcome Measures
Name Time Method ADAS-cog score;stroop test score;DCE-MRI imaging parameters (K-trans, Vp);Beck Depression Inventory score;Clinical Dementia Rating scire