Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-UMIN000031305
- Lead Sponsor
- Anti-Aging Bank Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
[1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3] Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [5]Individuals with history of gastrointestinal disorders except for appendicitis [6]Individuals with skin disease, such as atopic dermatitis [7]Individuals who have an inflammation or a scar on a measuring area [8]Individuals who will get sunburned during the test period [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [10]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [11]Individuals with serious anemia [12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [14]Individuals whose number of smokers exceeds 20 on average per day [15]Individuals whose life style will change during the test period (ex. travel for a long time) [16]Individuals who are pregnant or are posslibly, or are lactating [17]Individuals who participated in other clinical studies in the past three months [18]Individual with potential conflict of interest [19]Individuals judged inappropriate for the study by the principal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of occurrences of side effects, expression rate (number of side effect examples / number of subjects to be analyzed for safety)
- Secondary Outcome Measures
Name Time Method umber of occurrences of adverse events, incidence (number of adverse event developments / number of subjects to be analyzed for safety)