UMIN-CTR Clinical Trial

Basic information
Public title	Treatment of tongue coating for elderly patients requiring ~Comparison of the effects of the mouthwash stock solution and the foamed mouthwash~
Acronym	Treatment of tongue coating for elderly patients requiring ~Comparison of the effects of the mouthwash stock solution and the foamed mouthwash~
Scientific Title	Treatment of tongue coating for elderly patients requiring ~Comparison of the effects of the mouthwash stock solution and the foamed mouthwash~
Scientific Title:Acronym	Treatment of tongue coating for elderly patients requiring ~Comparison of the effects of the mouthwash stock solution and the foamed mouthwash~
Region	Japan

Condition
Condition	Independent daily living B and C 75years of oider
Classification by specialty	Cardiology Surgery in general Neurosurgery Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare togue care using a foamed mouthwash to reduce tongue coating in a short period of time without burdening the tongue
Basic objectives2	Others
Basic objectives -Others	Patient pain can bereduced by comparing and examining the shape of mouthwash that can care for tongue coating without burden on the tongue
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Foamed mouthwash group and Undiluted mouthwash group
Key secondary outcomes	TCR evaluation,TCI evaluation,ph measurement

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Comparison of the effects of the mouthwash stock solution and the foamed mouthwash
Interventions/Control_2	Check tongue surface ph with test strips
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Independent daily living B and C 75years of older
Key exclusion criteria	Person who can not obtain consent
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ami Middle name Last name Shimada
Organization	Aoyama General Hospital
Division name	2ward
Zip code	441-0195
Address	100-1 Doji Kozakai,Toyokawa,Aiti,Japan
TEL	0533-73-3777
Email	kangobu@aoyama-hp.or.jp

Public contact
Name of contact person	1st name Emi Middle name Last name Akamatsu
Organization	Nursing department
Division name	2ward
Zip code	441-0195
Address	100-1 Doji Kozakai, toyokawa,Aichi,Japan
TEL	0533-73-3777
Homepage URL
Email	kangobu@aoyama-hp.or.jp

Sponsor
Institute	Aoyama general Hospital Nursing departmentA
Institute
Department

Funding Source
Organization	Aoyama general Hospital
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	Aoyama general Hospital
Address	100-1 Doji Kozakai, toyokawa,Aichi,Japan
Tel	0533-73-3777
Email	kangobu@aoyama-hp.or,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 03 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	1
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 02 Month 10 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 30 Day
Date trial data considered complete	2021 Year 04 Month 30 Day
Date analysis concluded	2021 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 02 Month 11 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044986