Unique ID issued by UMIN | UMIN000038757 |
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Receipt number | R000044188 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2019/12/02 |
Last modified on | 2023/03/10 10:47:57 |
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial
A verification study of safety evaluation of excessive the test food consumption in humans
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To identify the safety of excessive consumption of the test food
Safety
Confirmatory
Pragmatic
Not applicable
1. Physical examination
2. Urinalysis
3. Blood test (hematological examination, blood biochemistry examination)
* Assess the measured values at screening (before consumption) and at two and four weeks after consumption and calculate the amount of change.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Food |
Duration: Four weeks
Test food: Tablet containing salmon nasal cartilage-derived proteoglycan
Administration: Take five tablets per day after dinner with water
* Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.
Duration: Four weeks
Test food: Placebo
Administration: Take five tablets per day after dinner with water
* Daily dose should be taken within the day. If you forget to take the capsule, 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. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
5. Currently taking medicines (include herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who are judged as ineligible to participate in the study by the physician
40
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
NIHON PHARMACEUTICAL CO.,LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
NO
2019 | Year | 12 | Month | 02 | Day |
Unpublished
44
Completed
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 12 | Month | 03 | Day |
2020 | Year | 02 | Month | 19 | Day |
2019 | Year | 12 | Month | 02 | Day |
2023 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044188
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