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
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
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
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
