Unique ID issued by UMIN | UMIN000032641 |
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Receipt number | R000037220 |
Scientific Title | A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study |
Date of disclosure of the study information | 2018/05/18 |
Last modified on | 2019/02/08 12:26:47 |
A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study
A verification study of safety evaluation of the test food long-term administration in humans
A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study
A verification study of safety evaluation of the test food long-term administration in humans
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To identify the safety of long-term administration of the recommended daily intake of test food for 12 weeks
Safety
Confirmatory
Pragmatic
Not applicable
1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)
* Assess these tests at screening and examination before consumption and at 4, 8, and 12 weeks after consumption
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Duration: 12 weeks
Test material: Active capsules
Dose: 2 capsules per day
Administration: Take one capsule with water after breakfast and another capsule after dinner
* Daily dose should be taken within the day. If you forget to take the capsules, take it as soon as you remember within the day.
Duration: 12 weeks
Test material: Placebo capsules
Dose: 2 capsules per day
Administration: Take one capsule with water after breakfast and another capsule after dinner
* Daily dose must be taken within the day. If you forget to take the capsules, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are judged as eligible to participate in the study by the physician
1. A medical history of malignant tumor, heart failure or myocardial infarction
2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, urinary bladder failure, or any other chronic diseases
3. Subjects who suffered or have been suffered from diseases related to the biliary tract
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
5. Subjects who currently taking medications (including herbal medicines) and supplements, particularly taking anticoagulants such as warfarin
6. Subjects who eat natto more than 3 times per week
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who are pregnant, breast-feeding, and planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
30
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
THERAVALUES CORPORATION
Profit organization
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2018 | Year | 05 | Month | 18 | Day |
Unpublished
Completed
2018 | Year | 05 | Month | 08 | Day |
2018 | Year | 05 | Month | 19 | Day |
2018 | Year | 05 | Month | 18 | Day |
2019 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037220
Research Plan | |
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