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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003918
Receipt No. R000004671
Scientific Title Olfactory stimulation using black pepper oil effects the clinical symptoms of geriatric syndrome in nursing home elderly
Date of disclosure of the study information 2010/07/16
Last modified on 2010/07/16

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Basic information
Public title Olfactory stimulation using black pepper oil effects the clinical symptoms of geriatric syndrome in nursing home elderly
Acronym Olfactory stimulation using black papper oil and Geraitric Syndrome(OBPGS Trial)
Scientific Title Olfactory stimulation using black pepper oil effects the clinical symptoms of geriatric syndrome in nursing home elderly
Scientific Title:Acronym Olfactory stimulation using black papper oil and Geraitric Syndrome(OBPGS Trial)
Region
Japan

Condition
Condition health-care associated pneumonia, fall, dementia
Classification by specialty
Medicine in general Pneumology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether the olfactory stimulation using black pepper oil inhibits the incidence of health care associated pneumonia,fall in the elderly, and to determine whether this odor affect cognitive function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the incidence of pneumonia,the number of fall and death in nursing home elderly
Key secondary outcomes the day of pyrexia, cognitive function and physical function

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Sheet where volatile black pepper oil adhered to multiple carbon nanoparticles continuously from and sheet without odor
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria all institutional elderly
Key exclusion criteria people who are unwilling to
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ebihara Satoru
Organization Tohoku University School of Medicine
Division name Dept of Internal medicine & rehabilitation
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku Univ. School of Medicine
Division name Dept. Internal Medicine & Rehabilitation Science
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Institute of Developement,Aging & Cancer,Tohoku University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
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 3老人保健施設および特養老人保健施設(宮城県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 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
2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 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
2010 Year 07 Month 16 Day
Last modified on
2010 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004671

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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