UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of aural repeated stimulation with ointment containing capsaicin on swallowing exercises in patients with dysphagia
Title of the study (Brief title)	Effects of aural repeated stimulation with ointment containing capsaicin on swallowing exercises 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 is made to examine effects of aural stimulation with ointment containing capsaicin for 4 weeks on swallowing exercises in tube-fed patients with dysphagia. Their swallowing is evaluated by transnasal videoendoscopy. The process of direct swallowing exercises, restoration of oral feeding and prevalence rate of aspiration pneumonia are also examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The process of direct swallowing exercises and restoration of oral feeding
Key secondary outcomes	The prevalence rate of aspiration pneumonia

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	Medicine
Interventions/Control_1	Aural repeated stimulation with ointment containing capsaicin
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	110 years-old >
Gender	Male and Female
Key inclusion criteria	Tube-fed patients with dysphagia
Key exclusion criteria	Patients who cannot follow an instruction of swallowing
Target sample size	40

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

Public contact
Name of contact person	Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Address	3-18-15 Kuramoto, Tokushima, Japan
TEL	088-633-7169
Homepage URL
Email	takeda@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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000015702