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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013443
Receipt No. R000015701
Scientific Title Effects of aural stimulation with ointment on swallowing function in patients with dysphagia
Date of disclosure of the study information 2014/05/01
Last modified on 2018/03/22

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Basic information
Public title Effects of aural stimulation with ointment on swallowing function in patients with dysphagia
Acronym Effects of aural stimulation with ointment on swallowing function in patients with dysphagia
Scientific Title Effects of aural stimulation with ointment on swallowing function in patients with dysphagia
Scientific Title:Acronym Effects of aural stimulation with ointment on swallowing function in patients with dysphagia
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the present study, an attempt was made to examine effects of aural stimulation with ointment on swallowing function in patients with dysphagia. Their swallowing was recorded by transnasal videoendoscopy and evaluated by the endoscopic swallowing score and SMRC scaling method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Swallowing function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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
Medicine
Interventions/Control_1 Aural stimulation with ointment with capsaicin
Interventions/Control_2 Aural stimulation with ointment without capsaicin
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with dysphagia
Key exclusion criteria Patients who cannot follow an instruction of swallowing
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Takeda
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address 3-18-15 Kuramoto, Tokushima, Japan
TEL 088-633-7169
Email takeda@clin.med.tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Takeda
Organization University of Tokushima School of Medicine
Division name Department of Otolaryngology
Zip code
Address 3-18-15 Kuramoto, Tokushima, Japan
TEL 088-633-7169
Homepage URL
Email takeda@clin.med.tokushima-u.ac.jp

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization self funding
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
Email

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 05 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
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 04 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 17 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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