UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019643
Receipt number R000020217
Scientific Title About the validity of the foot bathing with refinement to a patient with weariness
Date of disclosure of the study information 2015/11/06
Last modified on 2015/11/05 14:27:17

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Basic information

Public title

About the validity of the foot bathing with refinement to a patient with weariness

Acronym

About the validity of the foot bathing with refinement

Scientific Title

About the validity of the foot bathing with refinement to a patient with weariness

Scientific Title:Acronym

About the validity of the foot bathing with refinement

Region

Japan


Condition

Condition

Respiratory organs curculatory organ
deseaze

Classification by specialty

Cardiology Pneumology Chest surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

i perform a foot bath the using the essential oil and an essential oil-free foot bath and clarify an effect of the essential oil on general malaise

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

i have you fill in a questionnaire and add it up

Key secondary outcomes



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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

i perform a foot bath using the essential oil and an essential oil-free foot bath and perform two kinds of questionnaires before and after each foot bath and compare the effect

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

30 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

it is 140 from blood pressure 100 for the shrinkage period

it is 90 from diastolic bllod pressure 60

from pulse 60 for 100 times

it is 37 from temperature 35

Key exclusion criteria

other than the above

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name MONDEN NOBUO

Organization

Kawasaki Medical School affiliated hospital

Division name

Out of the 9th floor,ward

Zip code


Address

577,Matsushima,Kurashikishi,Okayama

TEL

086-462-1111

Email

clearveil-kizuna-th@docomo.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name MONDEN NOBUO

Organization

Kawasaki Medical School affiliated hospital

Division name

Out of the 9th floor,ward

Zip code


Address

577,Matsushima,Kurashiki-shi,Okayama

TEL

086-462-1111

Homepage URL


Email

clearveil-kizuna-th@docomo.ne.jp


Sponsor or person

Institute

Kawasaki Medical School affiliated hospital

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School affiliated hospital

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


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

2015 Year 11 Month 06 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

Enrolling by invitation

Date of protocol fixation

2015 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 06 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

2015 Year 11 Month 05 Day

Last modified on

2015 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name