UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022725 |
|---|---|
| Receipt number | 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 10:13:46 |
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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
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
ryaman@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024729
