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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031840 |
Receipt No. | R000036360 |
Scientific Title | A verification study of effectiveness of the black tea aroma to sleep |
Date of disclosure of the study information | 2018/03/24 |
Last modified on | 2020/10/09 |
Basic information | ||
Public title | A verification study of effectiveness of the black tea aroma to sleep | |
Acronym | A verification study of effectiveness of the black tea aroma to sleep | |
Scientific Title | A verification study of effectiveness of the black tea aroma to sleep | |
Scientific Title:Acronym | A verification study of effectiveness of the black tea aroma to sleep | |
Region |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To confirm the effectiveness to improvement of sleep by smelling the black tea aroma. |
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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | During 7 days of first term, smell the aroma of black tea for 3 hours a day at bedtime, with answer the questionnaires and measure the activity level. A day rest. During 7 days of second term, smell the aroma of control for 3 hours a day at bedtime, with answer the questionnaires and measure the activity level. | |
Interventions/Control_2 | During 7 days of first term, smell the aroma of control for 3 hours a day at bedtime, with answer the questionnaires and measure the activity level. A day rest. During 7 days of second term, smell the aroma of black tea for 3 hours a day at bedtime, with answer the questionnaires and measure the activity level. | |
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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | 054-639-0077 | ||||||
mtsuge@mitsui-norin.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
cpcc-contact@cpcc.co.jp |
Sponsor | |
Institute | CPCC Company Limited |
Institute | |
Department |
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 Chusin 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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036360 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |