UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034314 |
|---|---|
| Receipt number | R000039119 |
| Scientific Title | Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water. |
| Date of disclosure of the study information | 2018/09/28 |
| Last modified on | 2020/10/09 11:37:17 |
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Basic information
Public title
Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Acronym
Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Scientific Title
Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Scientific Title:Acronym
Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of action to human mind and body by smelling ethyl caproate and isoamyl acetate, those are primary ginjo-aroma of sake, then discover and use new knowledge of sake fragrance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of autonomic nervous system
Key secondary outcomes
Multifaceted emotional state scale shortened version
VAS questionnaire about change of feeling
VAS questionnaire about fragrance
VAS questionnaire about sake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Smell the scent of 2 kinds of component (A,B) in order A and B.
Interventions/Control_2
Smell the scent of 2 kinds of component (A,B) in order B and A.
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
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Females aged 25 to 45 years old.
(2)Subjects who like sake, especially ginjo-sake and have experience of drinking sake.
(3) 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 sake.
(2)Subjects who can't drink alcohol or who can drink alcohol little.
(3) Subjects who have smoking habit.
(4) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
(5) During the past month, subjects who have been received medication for the treatment of diseases.
(6) During the past month, subjects who have been received treatment of pollen allergy.
(7) Subjects who have stuffy nose from allergic rhinitis or who can't distinguish scent.
(8) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
(9) Subjects with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
(10) Pregnant or expected pregnant, or lactating women.
(11) Subjects who have symptom of dermatologic disease such as atopic dermatitis.
(12) Subjects who have undergone surgery on investigation objective portion within the past 6 months.
(13) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study.
(14) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells alcoholic beverages, health / functional foods and cosmetics.
(15) Others who have been determined ineligible by investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.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 Chusin 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
Gekkeikan Sake 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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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
| 2018 | Year | 09 | Month | 28 | 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
| 2018 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | 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=R000039119
