UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008946 |
|---|---|
| Receipt number | R000010489 |
| Scientific Title | Accelerating effect of applying capsaicin-containing film on the swallowing reflex - a double blind cross-over study - |
| Date of disclosure of the study information | 2012/09/19 |
| Last modified on | 2012/09/19 22:33:45 |
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Basic information
Public title
Accelerating effect of applying capsaicin-containing film on the swallowing reflex - a double blind cross-over study -
Acronym
Accelerating effect of a applying capsaicin-containing film on the swallowing reflex
Scientific Title
Accelerating effect of applying capsaicin-containing film on the swallowing reflex - a double blind cross-over study -
Scientific Title:Acronym
Accelerating effect of a applying capsaicin-containing film on the swallowing reflex
Region
| Japan |
Condition
Condition
Volunteered healthy person ( adult )
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Capsacine is said to have accelerating effect for emission of substance P (SP) that gives an influence to the swallowing and coughing reflex.
However, it is not clarified yet, the effect of capsicine in relation to the time of application to swallowing and coughing reflex.
This study aimed to evaluate the effect of film like a wafer containing capsaicin to the swallowing, coughing reflex and the chronological change of substance P in saliva by applied it on the oral mucosa.(mucosa on palate)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Acceleration effect on swallowing reflex
Key secondary outcomes
Rising of substance P in saliva
Acceleration of coughing reflex
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
Sample group applied capsaicin containing film
Interventions/Control_2
Sample group applied placebo film
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Volunteered healthy person (adult)
Key exclusion criteria
Person with the past of the asthmatic attack
Person with allergy to capsaicin
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomichi Murata |
Organization
Okayama University Hospital
Division name
The Center of Special Needs Dentistry
Zip code
Address
2-5-1, Shikato-cho, Kita-ku. Okayama City, Okayama Pref.
TEL
086-235-6823
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Goto |
Organization
Okayama University
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1, Shikato-cho, Kita-ku. Okayama City, Okayama Pref.
TEL
086-235-6823
Homepage URL
gmd421111@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Life Vitamin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
岡山大学 大学院医歯薬学総合研究科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 19 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 19 | Day |
Last modified on
| 2012 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010489
