UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032168 |
|---|---|
| Receipt number | R000036701 |
| Scientific Title | exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2019/10/23 14:45:09 |
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Basic information
Public title
exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia
Acronym
the effects of capsaicin
Scientific Title
exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia
Scientific Title:Acronym
the effects of capsaicin
Region
| Japan |
Condition
Condition
oropharyngeal dysphagia
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
| Endocrinology and Metabolism | Neurology | Infectious disease |
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of preventive effect of aspiration pneumonia
development of swallowing function evaluation method by ultrasound
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction of aspiration pneumonia incidence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
capsaicin group
Interventions/Control_2
placebo group
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients admitted to oropharyngeal dysphagia among inpatients
Key exclusion criteria
difficult to communicate with each other
impossible ingestion
active respiratory infection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | Nakato |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
701-0192
Address
577 Matsushima, Kurashiki
TEL
086-462-1111
cda40950@hkg.odn.ne.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | NAKATO |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
701-0192
Address
577 Matsushima, Kurashiki
TEL
086-462-1111
Homepage URL
pasteur_ui@yahoo.co.jp
Sponsor or person
Institute
Kawasaki mMedical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
Kawasaki Medical School, 577 Matsushima, Kurashiki 701-0192, Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
| 2018 | Year | 04 | Month | 10 | 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
0
Results
The approval of the Institutional Review Board was not obtained
Results date posted
| 2019 | Year | 10 | Month | 23 | Day |
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
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036701
| Research Plan | |
|---|---|
| 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 |
