Unique ID issued by UMIN | UMIN000030770 |
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Receipt number | R000035133 |
Scientific Title | An evaluation study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of plant extract |
Date of disclosure of the study information | 2018/01/14 |
Last modified on | 2018/05/01 12:56:31 |
An evaluation study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of plant extract
An evaluation study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of plant extract
An evaluation study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of plant extract
An evaluation study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of plant extract
Japan |
Healthy adult
Adult |
Others
NO
To confirm the decreasing effect of uncomfortable feelings in nose and eyes by long term consumption of plant extract.
Safety,Efficacy
Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ)
Secondary outcomes: nasal eosinophils, nonspecific IgE, Allergen-specific IgE (for 16 allergens), histamine, TNF-alpha.
Safety evaluation outcomes: physiological examination, hematological examination, blood biochemical examination, urine examination, presence or absence of side effects and adverse events during the test.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake 60 mL of test food a day, 12 consecutive weeks.
Intake 60 mL of placebo food a day, 12 consecutive weeks.
20 | years-old | <= |
59 | years-old | > |
Male and Female
(1)Male and female aged 20 to 59 when consent acquisition.
(2)Subjects who can intake test food every day.
(3)Subjects who notice themselves as they are mild/moderate hay fever and/or perennial allergic rhinitis.
(4)Subjects giving written informed consent.
(1) Subjects who have treated or taken medicine for perennial allergic rhinitis from 4 weeks before advance inspection to the end of the study.
(2) Subjects who planning some treatment during the examination period.
(3) Subjects who intake the medicines, the foods for specified health uses (FOSHU) and/or the health foods those are concerned their influence to test results.
(4) Pregnant or expected pregnant, and lactating women.
(5) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney.
(6) Subjects who excessive alcohol intake.
(7) Subjects who have smoking habit.
(8) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(9) Subjects who have previous medical history of drug and/or food, allergy, especially for Shiso leaf.
(10) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(11) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(12) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(13) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(16) Others who have been determined ineligible by principal investigator or sub-investigator.
50
1st name | |
Middle name | |
Last name | Suguru Fujiwara |
CPCC Co., Ltd.
Clinical Research Planning Department
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
cpcc-contact@cpcc.co.jp
1st name | |
Middle name | |
Last name | Makoto Ichinohe |
CPCC Co., Ltd.
Sales & Planning division
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
Emotent Co., Ltd.
Profit organization
NO
2018 | Year | 01 | Month | 14 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 21 | Day |
2018 | Year | 01 | Month | 15 | Day |
2018 | Year | 01 | Month | 11 | Day |
2018 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035133
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