Unique ID issued by UMIN | UMIN000021989 |
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Receipt number | R000025321 |
Scientific Title | A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial. |
Date of disclosure of the study information | 2016/04/19 |
Last modified on | 2017/03/02 16:25:08 |
A study for evaluating the immunostimulating effect
-A Randomized, double-blind, placebo controlled trial.
A study for evaluating the immunostimulating effect
A study for evaluating the immunostimulating effect
-A Randomized, double-blind, placebo controlled trial.
A study for evaluating the immunostimulating effect
Japan |
Healthy adults who feel fatigue
Medicine in general | Adult |
Others
NO
To evaluate the efficacy of test food on immune functions.
Efficacy
Scoring of Immunological Vigor after 4 weeks of intervention
Immunological parameters
Physical examinations
Urinary test
Blood test
Questionnaires (Likert)
:after 4 weeks of intervention
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Test food
Duration: 4 weeks
Dose: daily recommended dose
Usage: intake at optional timing
Placebo food
Duration: 4 weeks
Dose : daily recommended dose
Usage: intake at optional timing
20 | years-old | <= |
Not applicable |
Male and Female
a) Healthy adults, who feel fatigue
b) Persons whose ages are 20 years or older
c) Low immunity score (scoring immunological vigor: between 13 and 23) on visit 1's examination
a) Persons who have previous medical history of cancer, heart failure and cardiacinfarction
b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, digestive system disorder, autoimmune disorder, dyslipidemia, hypertension, and other chronic disease
c) Persons who takes medicines, herbal medicines, and dietary supplements
d) Persons who take in foods with an influence on Primary outcomes to more than three times a week in large quantities
e) Persons who take in foods with an influence on intestinal regulation to more than three times a week in large quantities
f) Persons who has allergy
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who enrolled in the other clinical trials within last 3 months before the agreement for the participation to the trial
i) Persons who investigator judge not suitable to participate in the trial
40
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Lotte Co., Ltd.
Profit organization
Seishin-kai medical Association Inc, Takara clinic.
NO
医療法人社団 盛心会 タカラクリニック(東京都)
Seishin-kai Medical Association Inc, Takara clinic(Tokyo)
2016 | Year | 04 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 19 | Day |
2016 | Year | 04 | Month | 20 | Day |
2016 | Year | 08 | Month | 09 | Day |
2016 | Year | 08 | Month | 09 | Day |
2016 | Year | 09 | Month | 21 | Day |
2016 | Year | 10 | Month | 12 | Day |
2016 | Year | 04 | Month | 19 | Day |
2017 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321
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