UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039296 |
|---|---|
| Receipt number | R000044816 |
| Scientific Title | Verification of salivary secretion promoting effect by orally disintegrating film. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/01/28 16:43:29 |
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Basic information
Public title
Verification of salivary secretion promoting effect by orally disintegrating film.
Acronym
Verification of salivary secretion promoting effect by orally disintegrating film.
Scientific Title
Verification of salivary secretion promoting effect by orally disintegrating film.
Scientific Title:Acronym
Verification of salivary secretion promoting effect by orally disintegrating film.
Region
| Japan |
Condition
Condition
Elderly people with suspected decrease in salivary secretion due to aging
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the salivary secretion-promoting effect of the orally disintegrating film containing sodium L-glutamate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An amount of saliva produced at rest before the start of the study.
An amount of saliva after ingesting the orally disintegrating film at the start of study.
An amount of saliva produced at rest on the 14th day of the study.
An amount of saliva after ingesting the orally disintegrating on the 14th day of the study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention period
14days
Intervention frequency
Ingest 6 orally disintegrating film a day, 2 in the morning, 2 in the afternoon and 2 in the evening, for 14 days.
Interventions/Control_2
Interventions/Control_3
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people 65 years and older, 10 men and 10 women, whose salivary secretion is expected to decrease due to aging. Those who have received sufficient explanation before participating in this study and who have agreed to participate in the study.
Key exclusion criteria
Subjects who have difficulty communicating.
Subjects who cannot ingest the film continuously during the study period due to deterioration of cognitive function or judgment ability.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL
03-5803-5559
harukatohara@hotmail.com
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL
03-5803-5559
Homepage URL
harukatohara@hotmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Tokyo Medical and Dental University, faculty of dentistry
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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
| 2020 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044816
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
