A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000036770
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 24
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. OSA sleep inventory 2. Pittsburgh Sleep Quality Index
- Secondary Outcome Measures
Name Time Method 1. SCL30 2. Activity level 3. The incidence of side effects and/or adverse events.