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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011228
Receipt No. R000013156
Scientific Title Influence on on blood flow of the aromatherapy
Date of disclosure of the study information 2013/07/22
Last modified on 2013/07/19

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Basic information
Public title Influence on on blood flow of the aromatherapy
Acronym Influence on on blood flow of the aromatherapy
Scientific Title Influence on on blood flow of the aromatherapy
Scientific Title:Acronym Influence on on blood flow of the aromatherapy
Region
Japan

Condition
Condition women volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the influence of counseling on the effectiveness of aromatherapy in 14 young women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective : multi-dimensional fatigue inventory-20 (MFI-20) Japanese version after treatment
Objective : blood flow by near-infrared spectroscopy (NIRS) after treatment
Key secondary outcomes Self-reported questionnaire (motivation, feeling of drowsiness and general fatigue),
Effectiveness of stress: The laterality index (LI) derived from NIRS measurements

Base
Study type Interventional

Study design
Basic design Single arm
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 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 aromatherapy by bergamot oil
Interventions/Control_2
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
22 years-old <=
Age-upper limit
28 years-old >=
Gender Female
Key inclusion criteria Participants who disliked the smell of bergamot were excluded.
Key exclusion criteria no problem
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakashima Emi
Organization Keio University faculty of pharmacy
Division name Division of pharmaceutics
Zip code
Address 105-8512 1-5-30 Shibakoen Minato-ku Tokyo Japan
TEL 03-5400-2660
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nakashima Emi
Organization Keio University faculty of pharmacy
Division name Division of pharmaceutics
Zip code
Address 105-8512 1-5-30 Shibakoen Minato-ku Tokyo Japan
TEL 03-5400-2660
Homepage URL
Email nakashima-em@pha.keio.ac.jp

Sponsor
Institute Keio University faculty of pharmacy
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grant
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
Email

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 慶應義塾大学 薬学部

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 22 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
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 29 Day
Last follow-up date
2012 Year 07 Month 06 Day
Date of closure to data entry
2012 Year 07 Month 31 Day
Date trial data considered complete
2012 Year 08 Month 05 Day
Date analysis concluded
2012 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 19 Day
Last modified on
2013 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013156

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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