UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019763 |
|---|---|
| Receipt number | R000022784 |
| Scientific Title | Psycho-physiological effects of inhalation of essential oils |
| Date of disclosure of the study information | 2015/11/12 |
| Last modified on | 2015/12/02 10:33:57 |
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Basic information
Public title
Psycho-physiological effects of inhalation of essential oils
Acronym
Psycho-physiological effects of essential oils
Scientific Title
Psycho-physiological effects of inhalation of essential oils
Scientific Title:Acronym
Psycho-physiological effects of essential oils
Region
| Japan |
Condition
Condition
Psychological stress of healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy adults to examine the changes and psycho-physiological effects of stress reaction in the before and after inhaling the smell of various essential oils.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Salivary cortisol
2.Psychological evaluation
Change levels before and after intervention
Comparison of aroma conditions and control conditions
3.Heart rate variability (measurement of the autonomic nervous system)
Change levels on intervention
Comparison of aroma conditions and control conditions
Key secondary outcomes
Inhalation of 15 minutes of essential oil steam
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
1)aroma 15min
2)washout 20min
3)no treatment 15min
Interventions/Control_2
1)no treatment 15min
2)washout 20min
3)aroma 15min
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
1) healthy women of age is less than 25 years of age or 20 years of age
2) those who understood the meaning of this test before the start of the test, signed the consent form
Key exclusion criteria
The subject of the following conditions
1) pregnancy, breastfeeding
2) chronic disease, acute disease
3) an abrupt change of living environment
4) acute disease, malignant tumor
5) allergies, respiratory diseases
6) of the skin abnormalities
7) Human investigator is judged unsuitable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Watanabe |
Organization
Kyoto Prefectural Univ. Med.
Division name
Dep. Immunology
Zip code
Address
Kajii-cyo 465, Kamikyo, Kyoto 602-8566, Japan
TEL
075-251-5329
e-w@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Watanabe |
Organization
Kyoto Prefectural Univ. Med.
Division name
Dep. Immunology
Zip code
Address
Kajii-cyo 465, Kamikyo, Kyoto 602-8566, Japan
TEL
075-251-5329
Homepage URL
https://kpu.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=383
e-w@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural Univ. Med.
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
RBMR-C-338
Org. issuing International ID_1
IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 12 | 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
| 2007 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022784
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
