UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037861 |
|---|---|
| Receipt number | R000043167 |
| Scientific Title | An evaluation test of influence to autonomic nervous by inhalation of the fragrances |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/10/09 11:56:44 |
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Basic information
Public title
An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Acronym
An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Scientific Title
An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Scientific Title:Acronym
An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider of influences of four kinds of fragrances which are included in black tea to autonomic nervous system and the optimum concentration of each fragrances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Evaluation of autonomic nervous system by pupillary measurement and skin temperature measurement
* VAS questionnaire of feeling about fragrances and mood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Test day 1 : measurement - suction of control fragrance - measurement - suction of fragrance A - measurement
Test day 2 : measurement - suction of control fragrance - measurement - suction of fragrance B - measurement
Test day 3 : measurement - suction of control fragrance - measurement - suction of fragrance C - measurement
Test day 4 : measurement - suction of control fragrance - measurement - suction of fragrance D - measurement
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Females aged 20 to 49 years old. (2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria
(1) Subjects who dislike the scent of black tea.
(2) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
(3) Subjects who have stuffy nose from allergic rhinitis or who can't distinguish scent.
(4) Pregnant or expected pregnant, or lactating women.
(5) Subjects who have undergone surgery on investigation objective portion, such as eye, forehead and/or fingertip, within the past 6 months.
(6) Others who have been determined ineligible by investigator.
Target sample size
20
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 426-0133, Japan
TEL
054-648-2600
masayuks@mitsui-norin.co.jp
Public contact
Name of contact person
| 1st name | Koharu |
| Middle name | |
| Last name | Okumura |
Organization
Mitsui Norin Co., Ltd.
Division name
Fundamental development team, R&D group
Zip code
426-0133
Address
223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan
TEL
054-648-2600
Homepage URL
k.okumura@mitsui-norin.co.jp
Sponsor or person
Institute
Mitsui Norin Co., Ltd.
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 Sanwauchikannda 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 | 09 | Month | 01 | 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
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 | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 08 | Month | 30 | 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=R000043167
