UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036770
Receipt number R000041897
Scientific Title A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
Date of disclosure of the study information 2020/05/17
Last modified on 2020/10/09 11:49:41

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Basic information

Public title

A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.

Acronym

A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.

Scientific Title

A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.

Scientific Title:Acronym

A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effectiveness to improvement of sleep by suction the aroma component of black tea.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. OSA sleep inventory
2. Pittsburgh Sleep Quality Index

Key secondary outcomes

1. SCL30
2. Activity level
3. The incidence of side effects and/or adverse events.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

During 7 days of first term, suction the aroma component of black tea for 3 hours a day at bedtime under natural respiration. A day rest. During 7 days of second term, suction control for 3 hours a day at bedtime under natural respiration.

Interventions/Control_2

During 7 days of first term, suction control for 3 hours a day at bedtime under natural respiration. A day rest. During 7 days of second term, suction the aroma component of black tea for 3 hours a day at bedtime under natural respiration.

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

30 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

(1) Females aged 30 to 45 years old who can't sleep well physiologically. (
For examples, female who can't fall in sleep within 30 min, female who have middle awakening and/or female who are short of sleeping time)
(2) Females who work over 4 days, 3.5 hours a day.
(3) Females who can quit using of smartphone, cell phone and/or PC from one hour before bedtime.
(4) Females who don't dislike black tea.
(5) Females who can quit drinking alcohol and caffeine after 5 pm during the test.
(6) Females who have no plan of going to travel and/or staying at outside of the home during the test.
(7) Females who can smell the aroma of black tea by diffuser at their own home during the test.
(8) 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 have smoking habit.
(2) Females who are cold-sensitive constitution. (including females like that who feel cold on their hands and foots even in summer)
(3) Females with stuffy nose or subjects who can't identify the fragrance.
(4) Females who are currently receiving medication due to treatment of disease.
(5) Females who go to hospital and/or subject who receive medicine, for treatment of sleep disorder.
(6) Females who use supplements and/or health foods suspected to have influence to sleep.
(7) 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.
(8) Females who notice their menopausal symptom.
(9) Females who are pregnant (including the possibility of pregnancy) or are lactating.
(10) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
(11) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
(12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics.
(13) Subjects who have environment for sleep with their children or family at bed time.
(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

054-639-2600

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

2020 Year 05 Month 17 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

24

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 04 Month 19 Day

Date of IRB

2019 Year 04 Month 19 Day

Anticipated trial start date

2019 Year 05 Month 17 Day

Last follow-up date

2019 Year 06 Month 01 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 05 Month 16 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=R000041897


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name