Unique ID issued by UMIN | UMIN000031305 |
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Receipt number | R000035621 |
Scientific Title | Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract |
Date of disclosure of the study information | 2018/02/15 |
Last modified on | 2018/07/06 12:05:15 |
Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
Japan |
Healthy volunteer
Adult |
Others
NO
The purpose of this study, the food with Kuromoji (Lindera umbellata) extract, is to verify the safety of when overdose.
Safety
Number of occurrences of side effects, expression rate (number of side effect examples / number of subjects to be analyzed for safety)
Number of occurrences of adverse events, incidence (number of adverse event developments / number of subjects to be analyzed for safety)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Oral ingestion of the test product (4 weeks)
Oral ingestion of the control product (4 weeks)
20 | years-old | <= |
65 | years-old | >= |
Male and Female
[1]Japanese males and females aged 20-65 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can come to the designated examination date and receive the examination
[5]Individuals judged appropriate for the study by the principal
[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
24
1st name | |
Middle name | |
Last name | Yoshikazu Yonei |
Faculty of Life and Medical Sciences,Doshisha University
Anti-Aging Medical Research Center
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
0774-65-6394
yyonei@mail.doshisha.ac.jp
1st name | |
Middle name | |
Last name | Tatsuya Honda |
DRC Co.,Ltd.
Product Testing & Studies Division
Tabuchi Bldg.No.9 3F,2-10-31,Higashi-Temma,Kita-ku,Osaka
06-6882-1130
honda@drc-web.co.jp
Anti-Aging Bank Co.,Ltd.
Yomeishu Seizo Co.,Ltd
Profit organization
Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program
NO
医療法人桜緑会日本橋さくらクリニック(東京都)
2018 | Year | 02 | Month | 15 | Day |
Unpublished
Completed
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 02 | Month | 15 | Day |
2018 | Year | 02 | Month | 14 | Day |
2018 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035621
Research Plan | |
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