Unique ID issued by UMIN | UMIN000034313 |
---|---|
Receipt number | R000039110 |
Scientific Title | A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial |
Date of disclosure of the study information | 2018/09/28 |
Last modified on | 2019/02/08 12:26:21 |
A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label 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 the test food to consume 5 times more than regular daily intake for 4 weeks in healthy Japanese subjects
Safety
Confirmatory
Pragmatic
Not applicable
1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)
* Assess these at screening (before consumption), at 2 and 4 weeks after consumption, and follow-up period for 2 weeks
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: 4 weeks
Test food: Manda Koso STANDARD or Manda Koso GINGER
Dose: Take 5 packs per day
Administration: Take 5 packs with water or lukewarm water after 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. 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, or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function Claims", or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplement (including health food)
6. Subjects who are an allergic reaction to medications and/or the test food related products (particularly oranges, walnuts, sesame seeds, soybeans, bananas, and apples)
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 enroll in anther clinical trials during trial period.
9. Subjects who are judged as ineligible to participate in the study by the physician
12
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.
MANDA FERMENTATION CO.,LTD.
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 | 09 | Month | 28 | Day |
Unpublished
Completed
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 09 | Month | 28 | Day |
2018 | Year | 09 | Month | 28 | Day |
2019 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039110
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |