Human study to evaluate the efficacy and safety of Dendropanax morbiferus leaves extract on cognitive function improvement
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0006329
- Lead Sponsor
- Ewha Womens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 85
1) Who agrees to participate in this study and signs a written agreement
2) Adult aged 50 to under 80
3) Who complains of subjective cognitive decline
1) Who is suspected of having dementia as a result of a neuropsychological examination
2) Who is diagnosed with any axis 1 psychiatric disorders
3) Who has suicidal ideation
4) Who has resistant Hypertension, uncontrolled diabetes, malignancy, severe cerebrovascular disease, heart disease, neuropsychological disease, traumatic brain damage accompanied by loss of consciousness or convulsions, acute stroke, severe hearing and vision impairment
5) Who has taken medications and health functional foods that may affect cognitive and memory function
6) Any contraindications to MRI
7) Who is diagnosed with an intellectual disability or less than a high school graduate
8) Participants in other clinical studies
9) Pregnant women or lactating women or persons who have plans for pregnancy
10) Who has hypersensitivity to ingredients contained in the experimental and placebo foods or has experienced severe food allergy reactions
11) Who is deemed inappropriate by investigators to participate in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cambridge Neuropsychological Test Automated Battery
- Secondary Outcome Measures
Name Time Method europsychological test and cognitive functional questionnaire;Brain imaging;Safety-related indicators (vital signs, clinical pathological testing);Safety-related indicators (abnormal reactions)