Unique ID issued by UMIN | UMIN000039348 |
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Receipt number | R000044866 |
Scientific Title | An evaluation study of change in auto-nervous system by suctioning of the aroma component. |
Date of disclosure of the study information | 2021/02/01 |
Last modified on | 2021/01/26 15:47:40 |
An evaluation study of change in auto-nervous system by suctioning of the aroma component.
An evaluation study of change in auto-nervous system by suctioning of the aroma component.
An evaluation study of change in auto-nervous system by suctioning of the aroma component.
An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Japan |
Healthy adults
Adult |
Others
NO
To verify the influence to auto-nervous system and to physiological actions by suctioning of the aroma component.
Safety,Efficacy
*Evaluation of autonomic nervous system (pupil versus light reflection, skin temperature)
* Evaluation of central nervous system (NIRS)
* Salivary substances (Chromogranin A, Oxytocin)
*Multiple mood scale (short version, 40 question)
*VAS questionnaire about fragrance and mood
* Incidence of adverse events and side effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Other |
Questionnaire - saliva sampling - presenting control sample - saliva sampling - presenting control sample - measuring autonomic nervous system - presenting test sampling - measuring autonomic nervous system - presenting test sampling - saliva sampling - presenting control sample - measuring skin surface temperature - presenting test sampling - measuring skin surface temperature - presenting control sample - measuring central nervous system - presenting test sampling - measuring central nervous system - saliva sampling - questionnaire
20 | years-old | <= |
40 | years-old | > |
Female
1) Females aged 20 to 39 years old when consent obtain.
2) Females who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
1) Females who dislike the fragrance of black tea
2) Females who have smoking habit.
3) Females who are cold-sensitive constitution.
4) Females who are receiving medication due to treatment of some disease within current one month before the test.
5) Females who are receiving treatment for pollen allergy within current one month before the test.
6) Females with stuffy nose such as allergic rhinitis or females who can't identify the fragrance.
7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
8) 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.
9) Females who are pregnant or are lactating.
10) Females who have symptom of dermatologic disease such as atopic dermatitis.
11) Females who have undergone surgery on investigation objective portion within the past 6 months.
12) Females who are being treated by dentist, or females who plan to go dentist for receiving treatment.
13) Females who are participating the other clinical tests of medicines or foods. Females who participated other clinical tests of medicines or foods within a month prior to the current study.
14) Others who have been determined ineligible by principal investigator or sub-investigator.
24
1st name | Masayuki |
Middle name | |
Last name | Suzuki |
Mitsui Norin Co., Ltd.
R&D Group
426-0133
223-1 Miyabara, Fujieda-city, Shizuoka-prefecture, 426-0133,JAPAN
054-648-2600
masayuks@mitsui-norin.co.jp
1st name | Masanori |
Middle name | |
Last name | Numa |
CPCC Company Limited
Planning & Sales Department
101-0047
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
Mitsui Norin Co., Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-5548
IRB@cpcc.co.jp
NO
2021 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2020 | Year | 01 | Month | 20 | Day |
2020 | Year | 01 | Month | 17 | Day |
2020 | Year | 02 | Month | 01 | Day |
2020 | Year | 02 | Month | 29 | Day |
2020 | Year | 01 | Month | 31 | Day |
2021 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044866
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