Unique ID issued by UMIN | UMIN000036672 |
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Receipt number | R000041788 |
Scientific Title | Safety confirmation test by intake of plant extract |
Date of disclosure of the study information | 2021/05/16 |
Last modified on | 2019/05/16 16:01:33 |
Safety confirmation test by intake of plant extract
Safety confirmation test by intake of plant extract
Safety confirmation test by intake of plant extract
Safety confirmation test by intake of plant extract
Japan |
Healthy Japanese adult
Adult |
Others
NO
The plant extract is taken by healthy men and women, and safety is confirmed.
Safety
Physical hand and physical examination
Hematology and blood biochemistry
Urinalysis
Journal
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Take the plant extract-containing food for 4 weeks to confirm safety.
20 | years-old | <= |
64 | years-old | > |
Male and Female
(1) Healthy men and women aged 20 to 79 years old
(2) BMI less than 30
(3) A person who has received a sufficient explanation of the purpose and contents of the study, has the ability to consent, voluntarily participates in a well-understood manner, and consents to the examination
(1) Liver disease, kidney disease, digestive system disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, seizures, and other diseases that may affect the results of this test Person who has a medical history or who has a history of surgery
(2) Patients who have been hospitalized for treatment due to stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, brain contusion, head injury
(3) Those who show abnormal liver function and renal function test values
(4) Person who has disease under treatment now
(5) Person with food and drug allergy
(6) Person with anemia symptom
(7) Those who have experienced ill mood or worsened physical condition by blood collection in the past
(8) Those who donated more than 200 mL from the month before the start of the test to the start of the test, or those who have plans for it during the test period
(9) Those who do intense sports and those who are on a diet
(10) Person who has excessive smoking habit
(11) Those who have an irregular diet
(12) Those who can not quit the intake of health food (including food for specified health and functional indication food) and designated quasi-drugs during the test period
(13) Those who are taking medication (including OTC and prescription drugs) continuously
(14) Those who are taking alcohol excessively or who can not drink alcohol from the day before the test until the day
(15) Persons who are pregnant or who are planning pregnancy or lactation during the study period
(16) Those who are participating in or planning to participate in other clinical trials at the beginning of this trial, and within 4 weeks after the end of the trial
(17) Others who are judged inappropriate by the investigator
22
1st name | Yoshiaki |
Middle name | |
Last name | Shiojima |
RYUSENDO CO., LTD.
President and CEO
171-0021
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
03-3985-8346
y.shiojima@ryusendo.co.jp
1st name | Megumi |
Middle name | |
Last name | Takahashi |
RYUSENDO CO., LTD.
Development Office
171-0021
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
03-3985-8346
m.takahashi@ryusendo.co.jp
Oneness support CO., LTD
RYUSENDO CO., LTD.
Profit organization
Medical corporation Kanonkai Miura clinic ethics review committee
Higasitenma Bld.9kai, 1-7-17, Higashitemma, Osaka Shi Kita Ku, Osaka Fu, 530-0044, Japan
06-6135-5200
mterashima@miura-cl.jp
NO
2021 | Year | 05 | Month | 16 | Day |
Unpublished
0
Terminated
2019 | Year | 04 | Month | 22 | Day |
2019 | Year | 04 | Month | 26 | Day |
2019 | Year | 05 | Month | 17 | Day |
2019 | Year | 07 | Month | 05 | Day |
2019 | Year | 05 | Month | 08 | Day |
2019 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041788
Research Plan | |
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Research case data specifications | |
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Research case data | |
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