UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014403 |
|---|---|
| Receipt number | R000015265 |
| Scientific Title | The effect of capsaicin for dysphagia and globus sensation - using Tissue Doppler Imaging - |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2019/10/17 14:36:27 |
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Basic information
Public title
The effect of capsaicin for dysphagia and globus sensation - using Tissue Doppler Imaging -
Acronym
The effect of capsaicin for dysphagia and globus sensation - using Tissue Doppler Imaging -
Scientific Title
The effect of capsaicin for dysphagia and globus sensation - using Tissue Doppler Imaging -
Scientific Title:Acronym
The effect of capsaicin for dysphagia and globus sensation - using Tissue Doppler Imaging -
Region
| Japan |
Condition
Condition
dysphagia, globus sensation
Classification by specialty
| Medicine in general | Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of tihs study is to evaluate of the effect on capsaicin for dysphagia andglobu sensation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of dysphagia and globus sensation
Key secondary outcomes
Prophylaxis for aspiration pneumonia
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 | Device,equipment |
Interventions/Control_1
The effect of capsaicin for dysphagia and globus sensation
Interventions/Control_2
Evaluation of motility at cervical by an ultrasonography
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients complaining of dysphagia or globs sensation.
Key exclusion criteria
A patient disagree with the study.
A patient who has an organic lesion by an upper gastrointestinal endoscopy.
A patient who is unfitted for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki MANABE |
Organization
Kawasaki medical school
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577 Matsushima, Kurashiki-City, Okayama Prefecture
TEL
086-462-1111
cda40950@hkg.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rui NAKATO |
Organization
Kawasaki medical school
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577 Matsushima, Kurashiki-City, Okayama Prefecture
TEL
086-462-1111
Homepage URL
cda40950@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki medical school
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
Address
Tel
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
| 2014 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015265
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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