UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026670
Receipt number R000030628
Scientific Title A verification study of psychological and physiological effect of the black tea smell
Date of disclosure of the study information 2017/03/23
Last modified on 2020/10/06 08:37:43

* 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

A verification study of psychological and physiological effect of the black tea smell

Acronym

A verification study of psychological and physiological effect of the black tea smell

Scientific Title

A verification study of psychological and physiological effect of the black tea smell

Scientific Title:Acronym

A verification study of psychological and physiological effect of the black tea smell

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By means of measurement of psychological and physiological responses to the black tea smell, clarify the function of that smell for mind and body.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Evaluation of autonomic nervous system
2. Evaluation of central nervous system
3. Questionnaires

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

Food

Interventions/Control_1

smell the scent of hot water - measurement - smell the scent of black tea - 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

25 years-old <=

Age-upper limit

40 years-old >=

Gender

Female

Key inclusion criteria

(1) Females aged 25 to 40 years old.
(2) Subjects who don't dislike black tea.
(3) Subjects 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) Subjects who have smoking habit.
(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 are currently receiving medication due to treatment of disease.
(4) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
(5) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
(6) Subjects with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
(7) Subjects who donated over 200mL blood within the last one month, or subjects who donated over 400mL blood within the last three month.
(8)Pregnant or expected pregnant, or lactating women.
(9) Subjects who have symptom of dermatologic disease such as atopic dermatitis.
(10) Subjects who have undergone surgery on investigation objective portion within the past 6 months.
(11) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study.
(12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics.
(13) Others who have been determined ineligible by investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

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

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chusin 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 Chushin 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

2017 Year 03 Month 23 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

2017 Year 03 Month 16 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 22 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

2017 Year 03 Month 23 Day

Last modified on

2020 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030628


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name