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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name