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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022725
Receipt No. R000024729
Scientific Title The effect of essential oil on the mood status and autonomic nervous system of healthy volunteers (pilot study)
Date of disclosure of the study information 2017/01/01
Last modified on 2019/07/31

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Basic information
Public title The effect of essential oil on the mood status and autonomic nervous system of healthy volunteers (pilot study)
Acronym Phase 1 study on essential oil
Scientific Title The effect of essential oil on the mood status and autonomic nervous system of healthy volunteers (pilot study)
Scientific Title:Acronym Phase 1 study on essential oil
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A pilot study to reveal the efficacy of essential oil to mood status and autonomic nervous system.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse events
Key secondary outcomes State-trait anxiety inventory
Autonomic nervous system function
Subjective evaluation of the odor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 lavandula officinalis
20 minutes of intervention
Interventions/Control_2 citrus bergamia
20 minutes of intervention
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

Not applicable
Gender Male and Female
Key inclusion criteria nursing students
Key exclusion criteria 1. respiratory allergic disease
2. smokers
3. other serious disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name RYUAY
Middle name
Last name YAMANAKA
Organization Kyoto Prefectural University of Medicine
Division name Graduate School for Health Care Science
Zip code 602-8566
Address 465 Kajii-cho, Kamigyoku, Kyoto 602-8566, Japan
TEL 075-212-5429
Email ryaman@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name RYUYA
Middle name
Last name YAMANAKA
Organization Kyoto Prefectural University of Medicine
Division name Graduate School for Health Care Science
Zip code 602-8566
Address 465 Kajii-cho, Kamigyoku, Kyoto 602-8566, Japan
TEL 0752125429
Homepage URL
Email ryaman@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization KYOTO PREFECTURAL UNIVERSITY OF MEDICINE
Address 465 Kajii-cho, Kamigyoku,Kyoto 602-8566, Japan
Tel 0752515337
Email rinri@koto.kpu-m.ac.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 京都府立医科大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 13 Day
Date of IRB
2016 Year 07 Month 14 Day
Anticipated trial start date
2017 Year 10 Month 26 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 13 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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