UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara)
Scientific Title	A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara)
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food containing fermented black jabara (Citrus jabara) for 4 weeks on allergy-like symptoms to impacts on daily life in healthy Japanese subjects with discomfort in their eyes and nose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ No1) * Assess the items at screening (before consumption) and 4 weeks after consumption.
Key secondary outcomes	1. Questionnaire based on practical guideline for the management of allergic rhinitis in Japan (record in the diary report) sneezing, runny nose, blocked nose, itchy eyes, and watery eyes 2. Specific IgE (Dermatophagoides pteronyssinus, animal dander, Japanese red-cedar, orchard grass, timothy grass, ragweed, and moth) 3. Eosinophils in the nasal discharge *1 Record the daily report every day from 1 week before starting consumption. *2, 3 Assess the items at screening (before consumption) and 4 weeks after 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	NO
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: 4 weeks Test Material: Active capsule Dosage: Take 3 capsules any time during the day with water or warm water * If you forget to take the capsules, take capsules as soon as you remember within the day.
Interventions/Control_2	Duration: 4 weeks Test Material: Placebo capsule Dosage: Take 3 capsules any time during the day with water or warm water * If you forget to take the capsules, take capsules as soon as you remember within 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. Healthy Japanese adult subjects 2. Subjects who are experiencing discomfort in their eyes and nose 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose total QOL score of JRQLQ No1 is relatively high at screening (before consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently 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 3. Subjects who are diagnosed with pollen allergy 4. Subjects who are diagnosed with allergic rhinitis 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who could have an allergy to raw materials of the test food, or possible to have serious allergic reactions to other foods and/or medicines 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	16

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	Nisshin Honey co.,ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	2018 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 06 Day
Date of IRB	2018 Year 08 Month 06 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date	2018 Year 11 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 10 Day
Last modified on	2019 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038432