UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety test of the aromatherapy using the essential oil which was extracted from natural green tea leaf
Title of the study (Brief title)	Safety test of the aromatherapy using the essential oil which was extracted from natural green tea leaf
Region	Japan

Condition
Condition	Healthy adults (In the future Alzheimer's disease)
Classification by specialty	Adult
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 the physical and mental.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The results of blood tests and blood pressure test after four weeks
Key secondary outcomes	The results of Touch Panel-type Dementia Assessment Scale (TDAS) and 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	Prevention
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 blood, blood pressure, 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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects who are 20-89 years old at the time of registration 2) Subjects who are not dementia
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) Pregnant women or the subjects who may become pregnant 6) Subjects who have abnormalities in skin patch test 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	2016 Year 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 28 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	2016 Year 07 Month 27 Day
Last modified on	2018 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026914