Unique ID issued by UMIN | UMIN000016220 |
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Receipt number | R000018822 |
Scientific Title | A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial. |
Date of disclosure of the study information | 2015/01/15 |
Last modified on | 2017/01/30 18:33:29 |
A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
A clinical trial to evaluate the effect of improving allergy-like symptoms
A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
A clinical trial to evaluate the effect of improving allergy-like symptoms
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
This trial aims to evaluate the effect of ingestion of the test foods on allergy-like symptoms such as rhinitis to subjects feeling these symptoms.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
[JRQLQ]
nasal symptom
ophthalmic symptom
QOL question
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Treatment
Food |
Duration: 8 weeks
Test material: Shiitake mycelium extract powder
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Duration: 8 weeks
Test material: Shiitake mycelium extract powder and Bifidobacterium BR108
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Duration: 8 weeks
Test material: Placebo
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
20 | years-old | <= |
Not applicable |
Male and Female
Healthy adults, who suffer from allergy-like symptoms
a.Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction
b.Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease
c.Persons who take medicines, herbal medicines, supplements related to test food.
d.Persons who take foods/drinks expected to be related with gut health, such as Food for Specified Health Uses (FOSHU), yogurt and, lactic fermenting beverage
e.Persons who are allergic to medicines, or products related to the test material of this trial
f. Persons who have been judged as pollinosis by doctors
g.Pregnant women, lactating women, or women who want to get pregnant during the trial period
h.Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
i.Persons who are judged not suitable to participate in this trial by physician
60
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
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.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Amino Up Chemical Co., Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
2015 | Year | 01 | Month | 15 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 14 | Day |
2015 | Year | 01 | Month | 16 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 05 | Month | 15 | Day |
2015 | Year | 05 | Month | 20 | Day |
2015 | Year | 05 | Month | 29 | Day |
2015 | Year | 01 | Month | 15 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018822
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