UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020525
Receipt number 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 17:52:32

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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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

Value
https://center6.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