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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039296
Receipt No. 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

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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
Email 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
Email harukatohara@hotmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044816

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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