UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032822 |
|---|---|
| Receipt number | R000037414 |
| Scientific Title | Assessment of the antimicrobial effect of gargling with yuzu juice. |
| Date of disclosure of the study information | 2018/06/05 |
| Last modified on | 2018/12/01 16:15:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of the antimicrobial effect of gargling with yuzu juice.
Acronym
Assessment of the antimicrobial effect of gargling with yuzu juice.
Scientific Title
Assessment of the antimicrobial effect of gargling with yuzu juice.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Prof. Shunji Mizobuchi |
Organization
Kochi Medical School, Kochi University
Division name
Clinical nursing
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-880-2564
mizoshun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Mizobuchi |
Organization
Kochi University
Division name
Clinical nursing, Kochi Medical School
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
088-880-2564
Homepage URL
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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 | 06 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037414
