UMIN-CTR Clinical Trial

Basic information
Public title	Effect of olfactory stimulation with Japanese cedar
Acronym	Effect of olfactory stimulation with Japanese cedar
Scientific Title	Effect of olfactory stimulation with Japanese cedar
Scientific Title:Acronym	Effect of olfactory stimulation with Japanese cedar
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to clarify the effect of olfactory stimulation with Japanese cedar on female university students using physiological and psychological indicators.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Near infrared spectroscopy 2) Heart rate variability 3) Heart rate
Key secondary outcomes	1) Modified semantic differential method 2) Kwansei Gakuin (KG) daily life questionnaire 3) Trait Anxiety of State-Trait Anxiety Inventory

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Olfactory stimulation Japanese cedar heartwood (90 s) -> Wash out period -> Olfactory stimulation with Japanese cedar sapwood (90 s) -> Wash out period -> Olfactory stimulation with room air (90 s)
Interventions/Control_2	Olfactory stimulation Japanese cedar heartwood (90 s) -> Wash out period -> Olfactory stimulation with room air (90 s) -> Wash out period -> Olfactory stimulation with Japanese cedar sapwood (90 s)
Interventions/Control_3	Olfactory stimulation with Japanese cedar sapwood (90 s) -> Wash out period -> Olfactory stimulation Japanese cedar heartwood (90 s) -> Wash out period -> Olfactory stimulation with room air (90 s)
Interventions/Control_4	Olfactory stimulation with Japanese cedar sapwood (90 s) -> Wash out period -> Olfactory stimulation with room air (90 s) -> Wash out period -> Olfactory stimulation Japanese cedar heartwood (90 s)
Interventions/Control_5	Olfactory stimulation with room air (90 s) -> Wash out period -> Olfactory stimulation Japanese cedar heartwood (90 s) -> Wash out period -> Olfactory stimulation with Japanese cedar sapwood (90 s)
Interventions/Control_6	Olfactory stimulation with room air (90 s) -> Wash out period -> Olfactory stimulation with Japanese cedar sapwood (90 s) -> Wash out period -> Olfactory stimulation Japanese cedar heartwood (90 s)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >
Gender	Female
Key inclusion criteria	Healthy person
Key exclusion criteria	1) Subjects who are in poor physical condition 2) Subjects who do not have respiratory illnesses 3) Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Miyazaki
Organization	Center for Environment, Health and Field Sciences, Chiba University
Division name	Nature Therapy Laboratory
Zip code	277-0882
Address	6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL	04-7137-8113
Email	ymiyazaki@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Miyazaki
Organization	Center for Environment, Health and Field Sciences, Chiba University
Division name	Nature Therapy Laboratory
Zip code	277-0882
Address	6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL	04-7137-8113
Homepage URL	http://www.fc.chiba-u.jp/research/miyazaki/index.html
Email	ymiyazaki@faculty.chiba-u.jp

Sponsor
Institute	Center for Environment, Health and Field Sciences, Chiba University
Institute
Department

Funding Source
Organization	SHIMIZU CORPORATION
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	The Ethics Committee of the Center for Environment, Health and Field Sciences, Chiba University
Address	6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel	04-7137-8010
Email	field-rinri@chiba-u.jp

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 09 Month 11 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 06 Month 30 Day
Date of IRB	2017 Year 07 Month 30 Day
Anticipated trial start date	2017 Year 09 Month 12 Day
Last follow-up date	2017 Year 10 Month 30 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 09 Month 11 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033279