A clinical study on the safety and efficacy of white ginseng extract in cognitive decline
- Conditions
- Not Applicable
- Registration Number
- KCT0006479
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
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
(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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mini-mental status examination score;adverse events, adverse drug reaction, serious AE/ADR, unexpected ADR
- Secondary Outcome Measures
Name Time Method ADAS-cog score;stroop test score ;Beck Depression Inventory score;Clinical Dementia Rating score