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
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
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
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
