UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053914 |
|---|---|
| Receipt number | R000061520 |
| Scientific Title | Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/02 16:04:51 |
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Basic information
Public title
Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial
Acronym
Clinical trial to investigate the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation
Scientific Title
Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial
Scientific Title:Acronym
Clinical trial to investigate the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation
Region
| Japan |
Condition
Condition
Young female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the short-term relaxation effects of Shikuwasa essential oil in young healthy adults, which is one of the less-studied varieties.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tense arousal subscale scores of the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist [JUMACL] after two minutes of inhalation of Shikuwasa essential oil fragrance or odour-free air.
Key secondary outcomes
1. The changes of miosis rate (autonomic nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes.
2. The changes in peripheral skin temperature (autonomic nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes.
3. The changes in cerebral blood flow (central nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes.
4. Visual Analogue Scale (VAS) evaluation of preference and impression regarding Shikuwasa essential oil inhalation or odour-free air inhalation.
5. Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
inhalation of Shikuwasa essential oil
Interventions/Control_2
Inhalation of odour-free air (non-active control condition)
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Female aged 18-39 years at the time of obtaining written informed consent.
2.Not being averse to the smell of citrus fruits, including Shikuwasa.
3.Expressing a willingness to participate in the study and providing voluntary consent by signing the informed consent form.
Key exclusion criteria
1.Having a history of or currently suffering from clinically problematic respiratory, gastrointestinal, hepatobiliary, haematological, renal, endocrine, cardiovascular, dermatological, or mental disorders.
2.Having a history of serious trauma or surgery within 12 weeks prior to the study.
3.Being sensitive to cold even in summer.
4.Unable to detect odours.
5.Having a history of or suspected allergy to foods (especially citrus fruits) or drugs requiring some kind of medical treatment.
6.Regularly taking psychotropic drugs (e.g. antidepressants, anxiolytics, or hypnotics)
7.Heavy smoker (21 or more cigarettes per day), heavy drinker (regularly drinking more than 60g pure alcohol per day), or having or suspected to have alcohol/substance misuse problems.
8.Regularly taking medicines, eating foods for specified health use, foods with function claims, or health food products that may affect the study results.
9.Being or possibly being pregnant or breastfeeding.
10.Have participated in other clinical trials within 4 weeks prior to the study.
11.Identifications of additional reasons, as deemed by study investigators, rendering the participant unsuitable for inclusion in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Health Care Research, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki (Kiyotake Branch)
Zip code
889-1692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Health Care Research, University of Miyazaki (Kiyotake Branch)
Zip code
889-1692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ogawa & 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
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.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
| 2024 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | 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
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061520
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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