UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
Acronym
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
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
Scientific Title:Acronym
Effects of the Consumption of Test Foods on Allergic Reactions of the Nose and Eyes Caused by Allergens
Region
| Japan |
Condition
Condition
Healthy Japanese subjects and subjects with mild symptoms
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Indena Japan Co., Ltd.
Indena S.p.A.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan and Italy
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/48110/1945
Number of participants that the trial has enrolled
66
Results
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
Results date posted
| 2021 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 27 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044194
