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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027692
Receipt No. R000031721
Scientific Title Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from Abies sachalinensis.
Date of disclosure of the study information 2017/06/09
Last modified on 2019/03/20

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Basic information
Public title Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from Abies sachalinensis.
Acronym Examination of the aromatherapy using the essential oil which was extracted from Abies sachalinensis
Scientific Title Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from Abies sachalinensis.
Scientific Title:Acronym Examination of the aromatherapy using the essential oil which was extracted from Abies sachalinensis
Region
Japan

Condition
Condition Alzheimer's disease, mild cognitive impairment
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate whether aromatherapy using the essential oil which was extracted from Abies sachalinensis affects for cognitive function in Alzheimer's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The results of Touch Panel-type Dementia Assessment Scale (TDAS) after four weeks
Key secondary outcomes The results of Odor Stick Identification Test for the Japanese, questionnaire and blood tests after four weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 In before and after using aromatherapy using the 100% essential oil which was extracted from Abies sachalinensis, we carry out test of cognitive function, olfactometry, questionnaires and blood tests. Subjects carry out the aromatherapy for two hours in the morning and two hours at night, and continue for four weeks
Interventions/Control_2 In before and after using aromatherapy using the 30% essential oil which was extracted from Abies sachalinensis, we carry out test of cognitive function, olfactometry, questionnaires and blood tests. Subjects carry out the aromatherapy for two hours in the morning and two hours at night, and continue for four weeks
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subjects who are more than 40 years old at the time of registration
2) Alzheimer's disease patients who fulfill of the DSM-5 and NINCDS-ADRDA criteria, or mild cognitive impairment patients who fulfill of the Petersen criteria.
3) The consent from proxies is necessary.
4) If the patient use antidementia medicine, it is necessary that cognitive function is stable

Key exclusion criteria 1) Subjects who have a serious allergic disease
2) Subjects who are diagnosed olfactory disturbance
3) Subjects who have a serious heart disease
4) Subjects who have the past of epilepsy
5) Subjects who are conducting other aromatherapy during the intervention period
6) Pregnant women
7) Subjects who are assessed by the principal investigator due to other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Urakami
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
Address 86 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6354
Email kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Kouzuki
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
Address 86 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6358
Homepage URL
Email kouzuki@med.tottori-u.ac.jp

Sponsor
Institute Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Japan Aroma Laboratory Co., Ltd.
Organization
Division
Category of Funding Organization Profit 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
2017 Year 06 Month 09 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
2017 Year 05 Month 31 Day
Date of IRB
2016 Year 10 Month 04 Day
Anticipated trial start date
2017 Year 06 Month 12 Day
Last follow-up date
2018 Year 08 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 08 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031721

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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