Unique ID issued by UMIN | UMIN000038765 |
---|---|
Receipt number | R000044194 |
Scientific Title | Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens: A Randomized Double-Blind Placebo-Controlled Trial |
Date of disclosure of the study information | 2020/07/31 |
Last modified on | 2021/05/24 10:01:05 |
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens: A Randomized Double-Blind Placebo-Controlled Trial
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
Japan |
Healthy Japanese subjects and subjects with mild symptoms
Clinical immunology | Adult |
Others
NO
The objective of this trial was to investigate the effects of a four-week, continuous consumption of the test food on subjective symptoms related to allergic reactions to allergens in Japanese adult with eye- and nose discomfort.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The measured values and changes on scores for each category and items of Japanese Rhino-conjunctivitis Quality of Life Questionnaire questionnaire at two and four weeks after the start of test-food consumption
The measured values and changes of subjective symptom scores based on the severity classification measurements of allergic rhinitis, eosinophils in nasal discharge, non-specific IgE, specific IgE (Dermatophagoides pteronyssinus, Japanese red-cedar, cypress, and house dust 1), and all VAS item scores at two and four weeks after the start of test-food consumption
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: Four weeks
Test food: Tablets containing flavonoids
Administration: Take a total of four tablets per day (two tablets after breakfast and other two tablets after dinner), ingested with water
* If you forget to take the tablets, take tablets as soon as you remember during the day.
Duration: Four weeks
Test food: Placebo
Administration: Take a total of four tablets per day (two tablets after breakfast and other two tablets after dinner), ingested with water
* If you forget to take the tablets, take tablets as soon as you remember during the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese males and females
2. Subjects with eye and nose discomfort
3. Subjects who are judged as eligible to participate in the trial by the physician
4. Subjects who have relatively high score in the nasal and eye symptoms score of JRQLQ at the point of screening
* Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects.
a. Healthy subjects:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects not using antiallergic drugs before and during the trial
b. Subjects with mild symptoms:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects who sometimes (not regularly) used ant allergic drugs before and during this trial
* "Sometimes" means using a drug as needed.
* "Regularly use" means using a drug at fixed intervals even if there are no symptoms.
1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake
5. Subjects receiving long-term drug treatment (Antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial
6. Subjects currently regularly taking medications (including herbal medicines) and supplements
7. Subjects allergic to medications and/or the test-food-related products
8. Subjects who cannot take the test food with the prescribed amount and ingestion method
9. Subjects who are planning to go abroad during this trial
10. Subjects who have a nasal irrigation habit
11. Subjects who are lactating, pregnant, or intending to become pregnant
12. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial
13. Subjects who are judged by the physician as ineligible to participate in the trial
60
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Indena Japan Co., Ltd.
Indena S.p.A.
Profit organization
Japan and Italy
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2020 | Year | 07 | Month | 31 | Day |
Unpublished
Published
http://www.pieronline.jp/content/article/0386-3603/48110/1945
66
Yamada S, Shirai M, Inaba Y, Takara T. Effects of repeated oral intake of the quercetin-containing supplement on allergic reaction-Randomized, placebo-controlled, double-blind parallel-group study-. Jpn Pharmacol Ther. 2020; 48(11): 1945-1959
2021 | Year | 05 | Month | 24 | Day |
2020 | Year | 11 | Month | 27 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 12 | Month | 03 | Day |
2020 | Year | 04 | Month | 04 | Day |
2019 | Year | 12 | Month | 03 | Day |
2021 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044194