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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020525
Receipt No. R000023289
Scientific Title The questionnaire survey in the effect of capsaicin intake for swallowing disorders of the nervous intractable disease patient
Date of disclosure of the study information 2016/01/14
Last modified on 2017/04/06

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Basic information
Public title The questionnaire survey in the effect of capsaicin intake for swallowing disorders of the nervous intractable disease patient
Acronym Questionnaire survey at the time of capsaicin intake to nerve intractable disease patient
Scientific Title The questionnaire survey in the effect of capsaicin intake for swallowing disorders of the nervous intractable disease patient
Scientific Title:Acronym Questionnaire survey at the time of capsaicin intake to nerve intractable disease patient
Region
Japan

Condition
Condition Nerve intractable disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A study of whether asked to ingestion of capsaicin to nerve intractable disease patient, effect on the swallowing reflex and the cough reflex, and the difference in the effect is observed by the disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of improving the swallowing reflex and cough reflex in capsaicin used before and used 6 months after.
Key secondary outcomes Immediately after use and before capsaicin use, after one week, one month later, the effect of improving the swallowing reflex and cough reflex after three months.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 ntervention period of 6 months. Three times a day, ingested before meals. Capsaicin sheet one intake at a time.
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

Not applicable
Gender Male and Female
Key inclusion criteria Nerve intractable disease patient adult. The possible person of mutual understanding. Those who can continue consultation.
Key exclusion criteria If you do not meet the selection criteria.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name naomichi murata
Organization Okayama University Hospital
Division name Special needs Dental Center
Zip code
Address Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL 086-235-6823
Email murat-n@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name tomoko higashi
Organization Okayama University (Graduate school)
Division name Special needs Dental Center
Zip code
Address Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL 086-235-6823
Homepage URL
Email po8o8zw7@s.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Special needs dentistry
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
2016 Year 01 Month 14 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
2015 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 14 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
2016 Year 01 Month 11 Day
Last modified on
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023289

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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