UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026879 |
|---|---|
| Receipt number | R000030785 |
| Scientific Title | Prophylactic effects of aural stimulation with capsaicin ointment on pneumonia in elderly patients |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/04/11 18:26:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takeda@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 770-8503, Japan
TEL
088-633-7169
Homepage URL
takeda@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030785
