UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032168
Receipt No. R000036701
Scientific Title exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia
Date of disclosure of the study information 2018/04/10
Last modified on 2018/07/19

* 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 exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia
Acronym the effects of capsaicin
Scientific Title exploratory study on the effects of capsaicin on hospitalized patient with oropharyngeal dysphagia
Scientific Title:Acronym the effects of capsaicin
Region
Japan

Condition
Condition oropharyngeal dysphagia
Classification by specialty
Medicine in general Gastroenterology Pneumology
Endocrinology and Metabolism Neurology Infectious disease
Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluation of preventive effect of aspiration pneumonia
development of swallowing function evaluation method by ultrasound
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes reduction of aspiration pneumonia incidence
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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
Food
Interventions/Control_1 capsaicin group
Interventions/Control_2 placebo group
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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients admitted to oropharyngeal dysphagia among inpatients
Key exclusion criteria difficult to communicate with each other
impossible ingestion
active respiratory infection
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rui Nakato
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography
Zip code
Address 577 Matsushima, Kurashiki
TEL 086-462-1111
Email cda40950@hkg.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rui NAKATO
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography
Zip code
Address 577 Matsushima, Kurashiki
TEL 086-462-1111
Homepage URL
Email cda40950@hkg.odn.ne.jp

Sponsor
Institute Kawasaki mMedical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 Month 10 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 10 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
2018 Year 04 Month 09 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.