UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005149 |
|---|---|
| Receipt number | R000006062 |
| Scientific Title | Influence of essential oils or stress on autonomic nervous system and immune system |
| Date of disclosure of the study information | 2011/02/27 |
| Last modified on | 2024/03/15 19:07:51 |
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Basic information
Public title
Influence of essential oils or stress on autonomic nervous system and immune system
Acronym
Influence of essential oils or stress on autonomic nervous system and immune system
Scientific Title
Influence of essential oils or stress on autonomic nervous system and immune system
Scientific Title:Acronym
Influence of essential oils or stress on autonomic nervous system and immune system
Region
| Japan |
Condition
Condition
normal adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
research question
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CVRR, salivary amylase, immune cells
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Stimulation testing of essential oils(Short-term test): Sniff time: 20 minutes/test, Test time: approximately 1 hour/test
[4 tests:1.placebo(water) (Wash-out period:1-2day) 2.essential oils (Wash-out period:1-2day) 3.stress + placebo(water) (Wash-out period:1-2day) 4.stress + essential oils]
Interventions/Control_2
Stimulation testing of essential oils(long-term test): Sniff time: 2 hours/day, continue one week, Test:Before and after the test, during testing, Test time: approximately 1 hour
Interventions/Control_3
Clinical exercise stress(clinical practice: April to August, Test:every two weeks, Test time: approximately 1 hour)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Having as underlying disease
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | kensaku |
| Middle name | |
| Last name | aki |
Organization
Institute of Health Biosciences,The tokushima Graduate School
Division name
Department of Cells and Immunity Analytics
Zip code
770-8509
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-9068
aki@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | kensaku |
| Middle name | |
| Last name | aki |
Organization
Institute of Health Biosciences,The tokushima Graduate School
Division name
Department of Cells and Immunity Analytics
Zip code
770-8509
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-9068
Homepage URL
aki@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Cells and Immunity Analytics, Institute of Health Biosciences,The tokushima Graduate School,
Institute
Department
Personal name
Funding Source
Organization
Association grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center for Developmental Therapeutics
Address
Tokushimasi Kuramotocho 2-50-1
Tel
088-633-9294
awachiken@clin.med.tokushima-u.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2011 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006062
| 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 |
