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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004222
Receipt No. 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

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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
Institute Tohoku University
Institute
Department

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
URL(English) https://upload.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


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