UMIN-CTR Clinical Trial

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

Alzheimer's disease, mild cognitive impairment

Classification by specialty

Neurology	Geriatrics	Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Japan Aroma Laboratory Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

06

Month

08

Day

Last modified on

2019

Year

03

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031721