UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039456 |
|---|---|
| Receipt number | R000044986 |
| Scientific Title | Treatment of tongue coating for elderly patients requiring ~Comparison of the effects of the mouthwash stock solution and the foamed mouthwash~ |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/02/14 04:11:45 |
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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
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
kangobu@aoyama-hp.or.jp
Sponsor or person
Institute
Aoyama general Hospital
Nursing departmentA
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
