Unique ID issued by UMIN | UMIN000042597 |
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Receipt number | R000048617 |
Scientific Title | A verification study for safety evaluation of long-term consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2021/05/31 11:11:34 |
A verification study for safety evaluation of long-term consumption of the test food
A verification study for safety evaluation of long-term consumption of the test food
A verification study for safety evaluation of long-term consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study for safety evaluation of long-term consumption of the test food
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the safety of long-term consumption of the test food for 12 weeks in healthy Japanese adult subjects
Safety
Confirmatory
Pragmatic
Not applicable
1. Incidence of side effects
2. Incidence of adverse events
1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before intervention).
2. Physical measurement
3. Urinalysis
4. Blood test
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Prevention
Food |
Duration: 12 weeks
Test food: Tablet containing garlic extract
Administration: Take three tablets per day with water at breakfast.
*If you forget to take the test food, take it as soon as you remember within the day.
Duration: 12 weeks
Test food: Placebo
Administration: Take three tablets per day with water at breakfast.
*If you forget to take the test food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. 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. Subjects who 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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who currently taking medications (including 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, or 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
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
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.
Daicel Corporation
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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
IRB@takara-clinic.com
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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2020 | Year | 11 | Month | 30 | Day |
Unpublished
22
Completed
2020 | Year | 11 | Month | 25 | Day |
2020 | Year | 11 | Month | 25 | Day |
2020 | Year | 12 | Month | 01 | Day |
2021 | Year | 04 | Month | 24 | Day |
2020 | Year | 11 | Month | 30 | Day |
2021 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048617
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