UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023016 |
|---|---|
| Receipt number | 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 09:59:20 |
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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
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
ryoma73@nih.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026528
