Unique ID issued by UMIN | UMIN000032857 |
---|---|
Receipt number | R000037468 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial |
Date of disclosure of the study information | 2018/06/04 |
Last modified on | 2019/06/04 10:02:19 |
A verification study of safety evaluation of excessive the test food consumption in humans: 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 the test food consumption in humans: 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 assess the safety of excessive the test food consumption
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) and at 4 weeks after consumption
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: 4 weeks
Test material: Processed food containing mixed extracts of Paris Polyphylla var. Yunnanensis (Franch.) Hand.-Mazz, Hedyotis diffusa Wild, and Scutellaria barbata D.DON
Dose: 10 packs per day
Administration: Take 10 packs per day any time during the day with water or warm water
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 diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
4. Subjects who are currently taking medications (including herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, or planning to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
8. Subjects who are judged as ineligible to participate in the study by the physician
10
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.
Seven Leaf Company
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
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 | 06 | Month | 04 | Day |
Unpublished
11
Completed
2018 | Year | 04 | Month | 09 | Day |
2018 | Year | 04 | Month | 10 | Day |
2018 | Year | 06 | Month | 05 | Day |
2018 | Year | 09 | Month | 22 | Day |
2018 | Year | 06 | Month | 04 | Day |
2019 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037468
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |