UMIN-CTR Clinical Trial

Basic information
Public title	Prophylactic effects of aural stimulation with capsaicin ointment on pneumonia in elderly patients
Acronym	Prophylactic effects of aural stimulation with capsaicin ointment on pneumonia in elderly patients
Scientific Title	Prophylactic effects of aural stimulation with capsaicin ointment on pneumonia in elderly patients
Scientific Title:Acronym	Prophylactic effects of aural stimulation with capsaicin ointment on pneumonia in elderly patients
Region	Japan

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

Objectives
Narrative objectives1	In the present double-blind randomized controlled trial study, an attempt was made to examine prophylactic effects of aural stimulation with capsaicin ointment on the incidence of pneumonia in elderly patients with a history of pneumonia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of pneumonia
Key secondary outcomes	The incidence of fever attack, the total dose of antibiotics used for the treatment of pneumonia, the incidence of urinary tract infection, oral intake dose, the score of ADL and the severity of dementia.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Aural stimulation with ointment containing 0.025% capsaicin.
Interventions/Control_2	Aural stimulation with ointment containing 0.00025% 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	65 years-old <=
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	Elderly patients with a history of pneumonia
Key exclusion criteria	Patients who was excluded by investigators
Target sample size	20

Research contact person
Last 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 770-8503, Japan
TEL	088-633-7169
Email	takeda@tokushima-u.ac.jp

Public contact
1st 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 770-8503, 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)

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	2017 Year 06 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	2017 Year 04 Month 06 Day
Date of IRB	2017 Year 05 Month 22 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 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	2017 Year 04 Month 05 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030785