UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of treatment using moisturizing gel with different antimicrobials for dry mouth in palliative medicine
Title of the study (Brief title)	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	Ryoma Nakao
Organization	National Institute of Infectious Diseases
Division name	Department of Bacteriology I
Address	1-23-1, Toyama, Shinjuku, Tokyo, Japan
TEL	+81-3-5285-1111
Email	ryoma73@nih.go.jp

Public contact
Name of contact person	Ryoma Nakao
Organization	National Institute of Infectious Diseases
Division name	Department of Bacteriology I
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
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

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Publication of results	Unpublished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