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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035953
Receipt No. R000040907
Scientific Title The Effect of Eucalyptol on Nursing Home Residents
Date of disclosure of the study information 2019/02/21
Last modified on 2019/02/20

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Basic information
Public title The Effect of Eucalyptol on Nursing Home Residents
Acronym Eucalyptol Scent
Scientific Title The Effect of Eucalyptol on Nursing Home Residents
Scientific Title:Acronym Eucalyptol Scent
Region
Japan

Condition
Condition Dementia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to study whether eucalyptol aroma is an effectiveness at reducing the symptoms of dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes MMSE, DBD, CMAI
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
78 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria residence of the nursing home
Key exclusion criteria no medication
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiko Goto
Organization Nagasaki University
Division name School of Environmental Science
Zip code
Address 1-14 Bunkyo-machi Nagasaki-shi Nagasaki
TEL 095-894-2740
Email gotos@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiko Goto
Organization Nagasaki University
Division name School of Environmental Science
Zip code
Address 1-14 Bunkyo-machi Nagasaki-shi Nagasaki
TEL 095-894-2740
Homepage URL
Email gotos@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
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
2019 Year 02 Month 21 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
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Two one-week single blind experiments were conducted between 6/18-6/24/2018, and 10/12-10/18/2018, approximately 4 months apart. Before and after each test, subjects and controls were tested using the MMSE (Mini-Mental State Examination), DBD (Dementia Behavior Disturbance scale), and CMAI (Cohen-Mansfield Agitation Inventory) (6/8-6/17, 6/25-7/3, 10/2-10/11, 10/19-10/25). During the second experiment, caregivers gave a simple memory test to the subject group. Follow-up DBD, CMAI, and MMSE tests were conducted for the control group three weeks after the second experiment (11/6).

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040907

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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