Unique ID issued by UMIN | UMIN000038343 |
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Receipt number | R000043699 |
Scientific Title | A study of effects of food containing herbal extract on throat discomfort |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2020/01/29 19:14:18 |
A study of effects of food containing herbal extract on throat discomfort
A study of effects of food containing herbal extract on throat discomfort
A study of effects of food containing herbal extract on throat discomfort
A study of effects of food containing herbal extract on throat discomfort
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the efficacy of the test food on throat or oral quality of life.
Efficacy
Japanese version of the Glasgow Edinburgh Throat Scale (GETS-J)
GOHAI (Geriatric Oral Health Assessment Index)
Anti-aging quality of life (Oral interview)
Opportunistic infection test
Salivary s-IgA concentration
Salivary secretion rate
Salivary s-IgA secretion rate
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of 5 grains of test food per day for 5 consecutive days
Intake of 5 grains of placebo per day for 5 consecutive days
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Males and females from 20 to 64 years of age
(2) Males and females with discomfort in the throat
(3) Subjects who can carry out opportunistic infection inspection
(4) Subjects who can visit designated medical institution on visit scheduled date
(5) Subjects who fully understands the purpose and content of this research and obtains written consent
(1) Subjects who take candy, or foods which richly contain the components of test food regularly
(2) Subjects who take health foods or supplements related to immune enhancement
(3) Subjects who had drag or treatment which affect result within 1 month
(4) Subjects who had treatment for tooth or mouth within 1 month
(5) Subjects who have troubles in the mouth
(6) Subjects who bleed more than once a week and cannot be prevented
(7) Subjects who work night and day shift or who work manual labor
(8) Subjects who regularly practice intense exercise such as marathons
(9) Subjects who cannot perform the procedures of various tests conducted during the research period as prescribed
(10) Subjects who have nervous system diseases or severe diseases such as, such as diabetes, liver disease, kidney disease, heart disease, and diseases that affect the secretion of corticosteroids
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects who are judged as unsuitable for laboratory value or physical examination value
(13) Subjects who are, or are planning to be pregnant or breastfeeding during study
(14) Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
(15) Subjects who are judged as unsuitable due to lifestyle questionnaire
(16) Subjects who are judged as unsuitable by doctor for other reasons
20
1st name | Naruhiko |
Middle name | |
Last name | Hongo |
Kanro Inc.
Research and Development Dept
135-0051
2-20-12, Edagawa, Koto Ku, Tokyo
03-5634-6000
Naruhiko_hongou@kanro.jp
1st name | Takashi |
Middle name | |
Last name | Nakagawa |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
0354595329
t.nakagawa@ttc-tokyo.co.jp
TTC Co., Ltd
Kanro Inc.
Profit organization
Aisei Hospital Ueno Clinic Research Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2020 | Year | 11 | Month | 30 | Day |
Unpublished
20
Completed
2019 | Year | 09 | Month | 12 | Day |
2019 | Year | 09 | Month | 12 | Day |
2019 | Year | 10 | Month | 21 | Day |
2019 | Year | 12 | Month | 25 | Day |
2019 | Year | 10 | Month | 20 | Day |
2020 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043699
Research Plan | |
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Research case data | |
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