Unique ID issued by UMIN | UMIN000041584 |
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Receipt number | R000047475 |
Scientific Title | The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult. |
Date of disclosure of the study information | 2020/08/28 |
Last modified on | 2021/02/26 10:36:30 |
The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.
The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.
The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.
The effect of test food on nasal and ocular discomfort and the QOL improvement effect for healthy adult.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate test food on nasal and ocular symptoms associated with house dust and mites for 8 weeks using placebo as a control.
Efficacy
QOL questionnaire, Diary of discomfort of eyes and nose.
Specific IgE (house dust and mites),
Eosinophils in nasal discharge,
Medical examination for check subjects nasal condition, and VAS-questionnaire.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of the test product for 8 consecutive weeks.
Ingestion of the placebo for 8 consecutive weeks.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1)Males and females from 20 to 64 years of age.
(2)Subjects who have frequently presence of nasal and ocular discomfort.
(3)Subjects who have positive for specific IgE against house dust or mites.
(4)Subjects who are judged as healthy person by the investigator.
(5)Subjects who do not take anti- allergic drug a count for more than half of whole.
(1)Subjects who are constantly using drugs or health food affecting nasal and ocular discomfort.
(2)Subjects who frequently visit a otorhinology.
(3)Subjects who have severe nasal symptoms.
(4)Subjects who are complicated by bronchial asthma.
(5)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(6)Subjects who are under medication which may influence the outcome of the study (e.g. specific desensitization therapy).
(7)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function.
(8)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(9)Subjects having possibilities for emerging allergy related to the study.
(10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(11)Subjects who have participated in other clinical studies at the time of this study start.
(12)Subjects who intend to become pregnant or lactation plan during
a study period.
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(14)Subjects judged as unsuitable for the study by the investigator for other reasons.
80
1st name | Takeshi |
Middle name | |
Last name | Zentani |
A・Pharma Kindai Co., Ltd.
Sales department
577-0818
3-5-14, Kowakae, Higashiosaka, Osaka
06-4307-5207
zentani@a-pharma-kindai.co.jp
1st name | Chiharu |
Middle name | |
Last name | Goto |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
c.goto@ttc-tokyo.co.jp
TTC Co., Ltd
A・Pharma Kindai Co., Ltd.
Profit organization
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguroku, Tokyo
03-6452-2712
t.saito@ttc-smo.jp
NO
2020 | Year | 08 | Month | 28 | Day |
Unpublished
Completed
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 08 | Month | 29 | Day |
2020 | Year | 12 | Month | 13 | Day |
2020 | Year | 08 | Month | 28 | Day |
2021 | Year | 02 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047475
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