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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031517
Receipt No. R000035986
Scientific Title A verification study of psychological and physiological effect of smell of Dashi extracted from the olive-iriko (Japanese anchovy boiled by salt water with olive leaves and then dried)
Date of disclosure of the study information 2018/02/28
Last modified on 2018/06/27

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Basic information
Public title A verification study of psychological and physiological effect of smell of Dashi extracted from the olive-iriko (Japanese anchovy boiled by salt water with olive leaves and then dried)

Acronym A verification study of psychological and physiological effect of smell of Dashi extracted from the olive-iriko

Scientific Title A verification study of psychological and physiological effect of smell of Dashi extracted from the olive-iriko (Japanese anchovy boiled by salt water with olive leaves and then dried)

Scientific Title:Acronym A verification study of psychological and physiological effect of smell of Dashi extracted from the olive-iriko

Region
Japan

Condition
Condition Healthy women
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By means of measurement of psychological and physiological responses to smell of Dashi extracted from the olive-iriko (Japanese anchovy boiled by salt water with olive leaves and then dried) clarify the function of that smell for mind and body.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Evaluation of autonomic nervous system
2. Evaluation of central nervous system
3. Questionnaires
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
Food
Interventions/Control_1 Suction air then testing. - Suction smell of hot water then testing. - Suction smell of Dashi extracted from the olive-iriko then testing.- Questionnaire.
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
26 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria 1)Females aged 26 to 40 years old.
2)Subjects who don't come with their child or children on the day of the study.
3)Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
4)Subjects who aren't bad at Dashi extracted from the olive-iriko (Japanese anchovy boiled by salt water with olive leaves and then dried)
5)Subjects who don't request disclosing of individual test results.
6)Subjects who won't claim to be disclosed results from the study and the measurement.
Key exclusion criteria 1) Subjects who have smoking habit.
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 are currently receiving medication due to treatment of disease.
4) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
5) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
6) 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.
7) Subjects who donated over 200mL blood within the last one month, or subjects who donated over 400mL blood within the last three month.
8)Pregnant or expected pregnant, or lactating women.
9) Subjects who have symptom of dermatologic disease such as atopic dermatitis.
10) Subjects who have undergone surgery on investigation objective portion within the past 6 months.
11) 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.
12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics.
13) Others who have been determined ineligible by investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Inoue
Organization Kamada Soy Sauce Inc.
Division name Department of technology
Zip code
Address 1-6-35 Honcho, Sakaide, Kagawa Prefecture 762-8602 JAPAN
TEL 0877-46-0001
Email inoue@kamada-soy.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Sales & Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute Kamada Soy Sauce Inc.
Institute
Department

Funding Source
Organization Kamada Soy Sauce Inc.
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
Address
Tel
Email

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 02 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 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 28 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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