Unique ID issued by UMIN | UMIN000037120 |
---|---|
Receipt number | R000042298 |
Scientific Title | A verification study for improving on the fatigue in a daily life with consumption of test food in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2019/06/20 |
Last modified on | 2019/12/27 09:41:32 |
A verification study for improving on the fatigue with consumption of test food
A verification study for improving on the fatigue with consumption of test food
A verification study for improving on the fatigue in a daily life with consumption of test food in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group study
A verification study for improving on the fatigue in a daily life with consumption of test food in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of the test food on the transient physical and mental fatigue in a daily life on the healthy subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. Questionnaire of fatigue (established by Japanese Society of Fatigue Science)
1. MOS Short-Form 36-Item Health. Survey (SF-36)
2. Scoring of immunological vigor
3. T lymphocyte age
4. Immunological age
5. Lymphocyte subset
6. Salivary immunoglobulin A (sIgA)
7. Profile of Mood States 2nd Edition (POMS2) Japanese version
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 4 weeks
Test food: Administration: Take 4 tablets with water after dinner
Duration: 4 weeks
Placebo food: Administration: Take 4 tablets with water after dinner
40 | years-old | <= |
70 | years-old | > |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who feel fatigue in daily
3. Subjects who are judged as eligible to participate in the study by the physician
4. Within the subjects who met 1st to 3rd inclusion criteria, subjects are selected in the descending order of VAS of fatigue. The scores of "Vigor-Activity" and "Fatigue-Inertia" of POMS2, and "Vitality" of SF-36 are taken into consideration.
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 diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, gastrointestinal disorder, or any other chronic diseases
4. Subjects who are diagnosed with eosinophilia
5. Subjects who have the medical history or under the treatment of Shiitake dermatitis
6. Subjects who are diagnosed with photosensitivity
7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
8. Subjects who are currently taking medications (including herbal medicines) and supplements
9. Subjects who are allergic to medicines and/or the test food related products
10. Subjects who are smokers
11. Subjects who are pregnant, lactation, or planning to become pregnant
12. 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 trial during trial period
13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
20
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.
KOBAYASHI 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
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)
2019 | Year | 06 | Month | 20 | Day |
Unpublished
22
Completed
2019 | Year | 03 | Month | 04 | Day |
2019 | Year | 03 | Month | 04 | Day |
2019 | Year | 06 | Month | 21 | Day |
2019 | Year | 10 | Month | 04 | Day |
2019 | Year | 06 | Month | 20 | Day |
2019 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042298
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |