UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023728
Receipt number R000027303
Scientific Title A survey on microcirculation (711)
Date of disclosure of the study information 2016/08/26
Last modified on 2016/10/27 16:05:00

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Basic information

Public title

A survey on microcirculation (711)

Acronym

A survey on microcirculation (711)

Scientific Title

A survey on microcirculation (711)

Scientific Title:Acronym

A survey on microcirculation (711)

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis the relationship between microcirculation and state of extremities.

Basic objectives2

Others

Basic objectives -Others

Analysis the relationship between microcirculation and state of extremities.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Objective indicators as microcirculation of extremities and so on.
-Subjective indicators as questionnaire.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

59 years-old >=

Gender

Male

Key inclusion criteria

-Healthy male

Key exclusion criteria

-Subjects who have been suffered from a critical disease
-Subjects who take prescription medicine
-Subjects with the illness of a vascular function
-Subjects with atopic dermatitis, eczema and pollen allergy
-Subjects with smoking habit
-Subjects who are in poor physical condition
-Subjects who have an abnormality of measurement skin site
-Subjects undergoing trauma in the measurement site
-Subjects who are influenced by the adhesive
-Subjects who participate in the other examinations which have an influence on this examination
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Murase

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7871

Email

murase.takatoshi@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daiji Kagawa

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7458

Homepage URL


Email

kagawa.daiji@kao.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

花王株式会社栃木事業場(栃木県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 26 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

2016 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 29 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects are recruited with the result of pre-questionnaire and without the key exclusion criteria


Management information

Registered date

2016 Year 08 Month 23 Day

Last modified on

2016 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027303


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name