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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032822
Receipt No. R000037414
Official scientific title of the study Assessment of the antimicrobial effect of gargling with yuzu juice.
Date of disclosure of the study information 2018/06/05
Last modified on 2018/06/01

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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 Preinitiation
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 06 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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