UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039348
Receipt number R000044866
Scientific Title An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Date of disclosure of the study information 2021/02/01
Last modified on 2021/01/26 15:47:40

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Basic information

Public title

An evaluation study of change in auto-nervous system by suctioning of the aroma component.

Acronym

An evaluation study of change in auto-nervous system by suctioning of the aroma component.

Scientific Title

An evaluation study of change in auto-nervous system by suctioning of the aroma component.

Scientific Title:Acronym

An evaluation study of change in auto-nervous system by suctioning of the aroma component.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the influence to auto-nervous system and to physiological actions by suctioning of the aroma component.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

*Evaluation of autonomic nervous system (pupil versus light reflection, skin temperature)
* Evaluation of central nervous system (NIRS)

Key secondary outcomes

* Salivary substances (Chromogranin A, Oxytocin)
*Multiple mood scale (short version, 40 question)
*VAS questionnaire about fragrance and mood
* Incidence of adverse events and side effects


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

Questionnaire - saliva sampling - presenting control sample - saliva sampling - presenting control sample - measuring autonomic nervous system - presenting test sampling - measuring autonomic nervous system - presenting test sampling - saliva sampling - presenting control sample - measuring skin surface temperature - presenting test sampling - measuring skin surface temperature - presenting control sample - measuring central nervous system - presenting test sampling - measuring central nervous system - saliva sampling - questionnaire

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

40 years-old >

Gender

Female

Key inclusion criteria

1) Females aged 20 to 39 years old when consent obtain.
2) Females who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

1) Females who dislike the fragrance of black tea
2) Females who have smoking habit.
3) Females who are cold-sensitive constitution.
4) Females who are receiving medication due to treatment of some disease within current one month before the test.
5) Females who are receiving treatment for pollen allergy within current one month before the test.
6) Females with stuffy nose such as allergic rhinitis or females who can't identify the fragrance.
7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
8) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
9) Females who are pregnant or are lactating.
10) Females who have symptom of dermatologic disease such as atopic dermatitis.
11) Females who have undergone surgery on investigation objective portion within the past 6 months.
12) Females who are being treated by dentist, or females who plan to go dentist for receiving treatment.
13) Females who are participating the other clinical tests of medicines or foods. Females who participated other clinical tests of medicines or foods within a month prior to the current study.
14) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

24


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-prefecture, 426-0133,JAPAN

TEL

054-648-2600

Email

masayuks@mitsui-norin.co.jp


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Numa

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

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 Sanwauchikanda 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

2021 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

Completed

Date of protocol fixation

2020 Year 01 Month 20 Day

Date of IRB

2020 Year 01 Month 17 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2020 Year 02 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 31 Day

Last modified on

2021 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name