UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056831 |
|---|---|
| Receipt number | R000064953 |
| Scientific Title | A questionnaire survey on changes in swallowing difficulty experienced by users of capsaicin-containing food sheets and in the burden of care for caregivers |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/01/27 13:37:52 |
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Basic information
Public title
A questionnaire survey on changes in swallowing difficulty experienced by users of capsaicin-containing food sheets and in the burden of care for caregivers
Acronym
The effective of capsaicin-containing food sheet
Scientific Title
A questionnaire survey on changes in swallowing difficulty experienced by users of capsaicin-containing food sheets and in the burden of care for caregivers
Scientific Title:Acronym
The effective of capsaicin-containing food sheet
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm, through a questionnaire survey, the swallowing difficulty experienced by subjects with spinal cord injury, etc., and the changes in the burden on caregivers, caused by the use of capsaicin-containing sheet foods commercially available in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the user's difficulty in swallowing and changes in the caregiver's burden
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Capsaicin-containing sheet
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects who are outpatients or inpatients at the Kibikogen Rehabilitation Center and have symptoms of dysphagia.
Key exclusion criteria
1. Minors who require an adult guardian.
2. Patients who are unable to take the medication orally.
3. Patients who are allergic to the ingredients in the capsaicin-containing sheets.
4. Patients who are unable to make their own decisions due to impaired consciousness, etc.
Target sample size
40
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, Okayama Prefecture
TEL
086-462-1111
r.nakato@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Murakami |
Organization
Kibikogen Rehabilitation Center
Division name
Speech Therapy
Zip code
716-1241
Address
7511 Yoshikawa, Kibichuo-cho, Kaga-gun, Okayama Prefecture
TEL
0866-56-7141
Homepage URL
ststaff@kibirihah.johas.go.jp
Sponsor or person
Institute
Kibikogen Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kibikogen Rehabilitation Center
Address
7511 Yoshikawa, Kibichuo-cho, Kaga-gun, Okayama Prefecture
Tel
0866-56-7141
ststaff@kibirihah.johas.go.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
| 2025 | Year | 01 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064953
