UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004222
Receipt number R000005064
Scientific Title Prevention of fall by lavender oil olfactory stimulation
Date of disclosure of the study information 2010/09/16
Last modified on 2011/02/23 14:51:35

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Basic information

Public title

Prevention of fall by lavender oil olfactory stimulation

Acronym

Lavender and fall

Scientific Title

Prevention of fall by lavender oil olfactory stimulation

Scientific Title:Acronym

Lavender and fall

Region

Japan


Condition

Condition

The frail elderly

Classification by specialty

Medicine in general Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose inspects an effect of fall preventive intervention of frail elderly using the olfactory stimulation of the lavender.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

A non-fall rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

The intervention group puts the seal to grind of the smell of the lavender every day.

Interventions/Control_2

The placebo group puts no-incense medical tape every day.

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

65 years-old <=

Age-upper limit

150 years-old >=

Gender

Male and Female

Key inclusion criteria

Ambulatory elderly (Don't ask it the use of the supporting in gredient).
The elderly who has transfer activity.

Key exclusion criteria

The person that an agreement is not obtained.
A bedridden elderly.
Allotriophagy.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoru Ebihara

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code


Address

Seiryo-machi 1-1, Aoba-ku, Sendai

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Welfare and labor

Organization

Division

Category of Funding 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



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 16 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

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2011 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 16 Day

Last modified on

2011 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name