UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from natural green tea leaf
Title of the study (Brief title)	Examination of the aromatherapy using the essential oil which was extracted from natural green tea leaf
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 natural green tea leaf 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 questionnaire after four weeks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	In before and after that subjects perform aromatherapy using aroma pendant in the morning, we carry out tests of cognitive function and questionnaires. Subjects carry out the aromatherapy for two hours a day and continue for four weeks.
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	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	40

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

Public contact
Name of contact person	Minoru Kouzuki
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
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	ACT-FO Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 31 Day
Anticipated trial start date	2017 Year 06 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 08 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031722