UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037861
Receipt number R000043167
Scientific Title An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Date of disclosure of the study information 2020/09/01
Last modified on 2020/10/09 11:56:44

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

An evaluation test of influence to autonomic nervous by inhalation of the fragrances

Acronym

An evaluation test of influence to autonomic nervous by inhalation of the fragrances

Scientific Title

An evaluation test of influence to autonomic nervous by inhalation of the fragrances

Scientific Title:Acronym

An evaluation test of influence to autonomic nervous by inhalation of the fragrances

Region

Japan


Condition

Condition

No applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider of influences of four kinds of fragrances which are included in black tea to autonomic nervous system and the optimum concentration of each fragrances.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

* Evaluation of autonomic nervous system by pupillary measurement and skin temperature measurement
* VAS questionnaire of feeling about fragrances and mood

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Test day 1 : measurement - suction of control fragrance - measurement - suction of fragrance A - measurement
Test day 2 : measurement - suction of control fragrance - measurement - suction of fragrance B - measurement
Test day 3 : measurement - suction of control fragrance - measurement - suction of fragrance C - measurement
Test day 4 : measurement - suction of control fragrance - measurement - suction of fragrance D - measurement

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

20 years-old <=

Age-upper limit

49 years-old >=

Gender

Female

Key inclusion criteria

(1) Females aged 20 to 49 years old. (2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.

Key exclusion criteria

(1) Subjects who dislike the scent of black tea.
(2) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
(3) Subjects who have stuffy nose from allergic rhinitis or who can't distinguish scent.
(4) Pregnant or expected pregnant, or lactating women.
(5) Subjects who have undergone surgery on investigation objective portion, such as eye, forehead and/or fingertip, within the past 6 months.
(6) Others who have been determined ineligible by investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Suzuki

Organization

Mitsui Norin Co., Ltd.

Division name

R&D group

Zip code

426-0133

Address

223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan

TEL

054-648-2600

Email

masayuks@mitsui-norin.co.jp


Public contact

Name of contact person

1st name Koharu
Middle name
Last name Okumura

Organization

Mitsui Norin Co., Ltd.

Division name

Fundamental development team, R&D group

Zip code

426-0133

Address

223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan

TEL

054-648-2600

Homepage URL


Email

k.okumura@mitsui-norin.co.jp


Sponsor or person

Institute

Mitsui Norin Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Mitsui Norin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.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

2020 Year 09 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

Completed

Date of protocol fixation

2019 Year 08 Month 19 Day

Date of IRB

2019 Year 08 Month 16 Day

Anticipated trial start date

2019 Year 09 Month 09 Day

Last follow-up date

2019 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

2019 Year 08 Month 30 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043167


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name