UMIN-CTR Clinical Trial

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
Email	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
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044194