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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032773
Receipt No. R000037389
Scientific Title A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Date of disclosure of the study information 2018/05/31
Last modified on 2020/10/09

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Basic information
Public title A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Acronym A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Scientific Title A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Scientific Title:Acronym A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Region
Japan

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

Objectives
Narrative objectives1 By measuring psychological and physiological responses to the aroma of the oils extracted from citrus (orange, iyokan and yuzu), to clarify the functions of those aroma against 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 parasympathetic nervous system
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 First term: 5 min rest - measurement - 5 min suction of test sample 1 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).
Interventions/Control_2 First term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 1 - measurement ( repeat this sequence on five other kind of measurements).
Interventions/Control_3 First term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 1 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).
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
30 years-old >=
Gender Male and Female
Key inclusion criteria 1.Males and females aged 20 to 30 years when informed consent.
2.Subjects who aren't bad at the aroma of citrus (orange, iyokan and yuzu).
3.Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
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 a 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.Pregnant or expected pregnant, or lactating women.
7.Subjects who have symptom of dermatologic disease such as atopic dermatitis.
8.Subjects who have undergone surgery on investigation objective portion within the past 6 months.
9.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.
10.Subjects who themselves and/or their family are working for a company that develops and/or manufactures beverage.
11.Other who is determined ineligible by investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name Ohata
Organization NIHON UNIVERSITY
Division name College of Bioresource Science
Zip code 252-0880
Address 1866 Kameino, Fujisawa-shi, Kanagawa 252-0880 Japan
TEL 0466-84-3987
Email oohata.motoko@nihon-u.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Yada
Organization University of Tsukuba School of Integrative
Division name Global Majors
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL 029-853-7344
Homepage URL
Email yada.yukihiri.gb@u.tsukuba.ac.jp

Sponsor
Institute NIHON UNIVERSITY
Institute
Department

Funding Source
Organization University of Tsukuba
School of Integrative
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 Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel 03-5297-5548
Email 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 05 Month 31 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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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 05 Month 30 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037389

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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