UMIN-CTR Clinical Trial

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
Last 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
1st 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