Unique ID issued by UMIN | UMIN000053541 |
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Receipt number | R000061099 |
Scientific Title | Safety overdose study intake foods containing plant extracts : Open-label study |
Date of disclosure of the study information | 2024/02/05 |
Last modified on | 2024/02/05 09:11:30 |
Safety overdose study intake foods containing plant extracts
Safety overdose study intake foods containing plant extracts
Safety overdose study intake foods containing plant extracts
: Open-label study
Safety overdose study intake foods containing plant extracts
: Open-label study
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the safety of overdose of foods containing plant extracts at five times the normal dose
Safety
Adverse event
Physical examination (blood pressure, pulse)
Laboratory test values (Hematology, blood biochemistry, urinalysis)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingestion of research food for 12 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Subjects of men and women aged 20 to 64
(2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
(1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral angiopathy, or other serious disease
(2) Subjects who have undergone gastrointestinal surgery
(3) Subjects with abnormal liver and renal function test values
(4) Subjects who are currently undergoing treatment for a disease
(5) Subjects who are allergic to food or drugs
(6) Subjects with anemia symptoms
(7) Women who wish to become pregnant (including possible pregnancy) or lactating women during participation in this study
(8) Subjects who play intense sports and subjects who are on a diet
(9) Subjects with extremely irregular eating habits
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs)
(12) Subjects who drink more than 60 g of average daily pure alcohol
(13) Subjects who smoke an average of 21 or more cigarettes a day
(14) Subjects who are participating or will participate in other clinical trials at the start of this study
(15) Subjects who are judged to be unsuitable for the study by the investigator.
15
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal medicine
5300044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
5300044
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
TOWA CORPORATION
Profit organization
The Ethics Committee of Miura Clinic, Medical Corporation, Kanonkai
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪府)
2024 | Year | 02 | Month | 05 | Day |
Unpublished
Preinitiation
2024 | Year | 01 | Month | 29 | Day |
2024 | Year | 02 | Month | 01 | Day |
2024 | Year | 03 | Month | 08 | Day |
2024 | Year | 04 | Month | 30 | Day |
2024 | Year | 02 | Month | 05 | Day |
2024 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061099
Research Plan | |
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Research case data specifications | |
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Research case data | |
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