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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023016
Receipt No. R000026528
Scientific Title Effect of treatment using moisturizing gel with different antimicrobials for dry mouth in palliative medicine
Date of disclosure of the study information 2016/07/22
Last modified on 2017/06/07

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Basic information
Public title Effect of treatment using moisturizing gel with different antimicrobials for dry mouth in palliative medicine
Acronym Oral-moisturizing gel for palliative medicine
Scientific Title Effect of treatment using moisturizing gel with different antimicrobials for dry mouth in palliative medicine
Scientific Title:Acronym Oral-moisturizing gel for palliative medicine
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate microbiological effect of oral moisturizing gel containing antimicrobial derived from food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Microbes in saliva
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 250 ug/ml Propolis
Interventions/Control_2 30 ug/ml Curry leaf
Interventions/Control_3 62.5 ug/ml Turmeric
Interventions/Control_4 Placebo
Interventions/Control_5 0.05% Glucuronic chlorhexidine
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 Head and neck cancer patients
who has already received irradiation therapy at not less than 50 Gy.
Key exclusion criteria Experience of any antibiotics usage within 3 mounths
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoma Nakao
Organization National Institute of Infectious Diseases
Division name Department of Bacteriology I
Zip code
Address 1-23-1, Toyama, Shinjuku, Tokyo, Japan
TEL +81-3-5285-1111
Email ryoma73@nih.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Nakao
Organization National Institute of Infectious Diseases
Division name Department of Bacteriology I
Zip code
Address 1-23-1, Toyama, Shinjuku, Tokyo, Japan
TEL +81-3-5285-1111
Homepage URL
Email ryoma73@nih.go.jp

Sponsor
Institute National Institute of Infectious Diseases
Institute
Department

Funding Source
Organization Yamada Research Foundation
Sasakawa Foundation
Urakami Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 22 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
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 11 Day
Last follow-up date
2017 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026528

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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