UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020577 |
|---|---|
| Receipt number | R000023757 |
| Scientific Title | Study on Aromatherapy using Magnetoencepharography |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/08/14 18:36:06 |
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Basic information
Public title
Study on Aromatherapy using Magnetoencepharography
Acronym
MEG analysis in Aromatherapy
Scientific Title
Study on Aromatherapy using Magnetoencepharography
Scientific Title:Acronym
MEG analysis in Aromatherapy
Region
| Japan |
Condition
Condition
Normal volunteers and epilepsy patients
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify some effects on brain function by aromatherapy
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety of aromatherapy
Key secondary outcomes
Efficacy of aromatherapy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Trans-nasal administration of aroma essence 1
Trans-nasal administration of aroma essence 2
Trans-nasal administration of placebo control
Interventions/Control_2
Trans-nasal administration of aroma essence 1
Trans-nasal administration of placebo control
Trans-nasal administration of aroma essence 2
Interventions/Control_3
Trans-nasal administration of aroma essence 2
Trans-nasal administration of aroma essence 1
Trans-nasal administration of placebo control
Interventions/Control_4
Trans-nasal administration of aroma essence 2
Trans-nasal administration of placebo control
Trans-nasal administration of aroma essence 1
Interventions/Control_5
Trans-nasal administration of placebo control
Trans-nasal administration of aroma essence 1
Trans-nasal administration of aroma essence 2
Interventions/Control_6
Trans-nasal administration of placebo control
Trans-nasal administration of aroma essence 2
Trans-nasal administration of aroma essence 1
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal volunteers without any history of neurological diseases
Epilepsy patients
Key exclusion criteria
Pearson with metal inside the body
Pearson who can not stay in quiet
Pearson who is not suit for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takufumi Yanagisawa |
Organization
Osaka University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yamadaoka Suita Osaka
TEL
06-6879-3652
tyanagisawa@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takufumi Yanagisawa |
Organization
Osaka University
Division name
Department of neurosurgery
Zip code
Address
1-1 Yamadaoka Suita Osaka
TEL
06-6879-3652
Homepage URL
http://www.nsurg.med.osaka-u.ac.jp/
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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
| 2016 | Year | 02 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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
| 2016 | Year | 01 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023757
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
