UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the antimicrobial effect of gargling with yuzu juice.
Title of the study (Brief title)	Assessment of the antimicrobial effect of gargling with yuzu juice.
Region	Japan

Condition
Condition	Healthy Volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to evaluate the safety of gargling with yuzu juice and to examine whether or not this has antibacterial action.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the total number of bacteria in the oral cavity before and after gargling with yuzu juice.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects gargle with yuzu juice.
Interventions/Control_2	Subjects gargle with water.
Interventions/Control_3	Subjects gargle with povidone-iodine gargle solution.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Those who receive an appropriate explanation of the purpose and content of the study, are able to consent, voluntarily request to participate after gaining a full understanding, and are able to consent to participation in this survey in writing. 2. Healthy individuals
Key exclusion criteria	1. Individuals with an iodine allergy. 2. Individuals with a fruit allergy. 3. Other individuals deemed unsuitable by the principal investigator.
Target sample size	25

Research contact person
Name of lead principal investigator	Prof. Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-880-2564
Email	mizoshun@kochi-u.ac.jp

Public contact
Name of contact person	Shunji Mizobuchi
Organization	Kochi University
Division name	Clinical nursing, Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-880-2564
Homepage URL
Email	mizoshun@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Kochi University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 05 Day
Anticipated trial start date	2018 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 01 Day
Last modified on	2018 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037414