UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052026 |
|---|---|
| Receipt number | R000054762 |
| Scientific Title | Effects of geranium essential oil on the autonomic nervous system during aromatherapy treatment in healthy subjects. In a state where the sense of smell is eliminated |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/08/28 14:57:54 |
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Basic information
Public title
Effects of geranium essential oil in aromatherapy treatment of healthy subjects
Acronym
Effects of Aromatherapy Treatment
Scientific Title
Effects of geranium essential oil on the autonomic nervous system during aromatherapy treatment in healthy subjects. In a state where the sense of smell is eliminated
Scientific Title:Acronym
Effects of geranium essential oil on the autonomic nervous system
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite the fact that many people have realized the effectiveness of aromatherapy, it is not actively used in medicine due to a lack of scientific elucidation.
In this application, research will be conducted to scientifically elucidate aromatherapy, focusing on treatment in a state where the sense of smell is eliminated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability will be analyzed from heartbeats obtained from fingertip and ear pulse waves immediately before (10 minutes), during (10 minutes), and after (10 minutes) aromatherapy treatments to determine the effects on the autonomic nervous system.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment with control oil (macadamia nut oil)
Interventions/Control_2
Treatment with oil containing 1% geranium essential oil
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female students of International University of Health and Welfare, College of Pharmacy and Graduate School of Pharmacy who are willing to help us as volunteers.
Key exclusion criteria
Students with chemical sensitivity, skin conditions on the arms, or allergic diseases such as bronchial asthma or atopic dermatitis will be excluded in advance, as well as students with suspected allergies based on patch tests conducted in advance.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Satou |
Organization
International University of Health and Welfare
Division name
Pharmaceutical Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Ohtawara, Tochigi
TEL
0287-24-3591
tsatou@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tadaaki |
| Middle name | |
| Last name | Satou |
Organization
International University of Health and Welfare
Division name
Pharmaceutical Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Ohtawara, Tochigi
TEL
0287-24-3591
Homepage URL
tsatou@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi District Ethics Review Committee
Address
2600-1 Kitakanemaru, Ohtawara, Tochigi
Tel
0287-24-3125
s-rinri@iuhw.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21-Io-47
Org. issuing International ID_1
Tochigi District Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国際医療福祉大学 薬学部
Other administrative information
Date of disclosure of the study information
| 2023 | 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
8
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
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054762
