UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053569 |
|---|---|
| Receipt number | R000056735 |
| Scientific Title | Research on the effects of aromatherapy treatment on the autonomic nervous system in healthy subjects excluded from olfactory stimulation. -Presence of mild stress, presence of various essential oils- |
| Date of disclosure of the study information | 2024/02/07 |
| Last modified on | 2024/02/07 18:53:38 |
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Basic information
Public title
Research on the effects of aromatherapy treatment on the autonomic nervous system in healthy subjects excluded from olfactory stimulation.
Acronym
Research on the effects of aromatherapy treatment on the autonomic nervous system
Scientific Title
Research on the effects of aromatherapy treatment on the autonomic nervous system in healthy subjects excluded from olfactory stimulation. -Presence of mild stress, presence of various essential oils-
Scientific Title:Acronym
Research on the effects of aromatherapy treatment on the autonomic nervous system in healthy subjects excluded from olfactory stimulation.
Region
| Japan |
Condition
Condition
autonomic nervous system disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to scientifically elucidate the effects of aromatherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase 1.
The effects of the presence and absence of essential plant oils and the effects of different types of essential plant oils will be conducted twice with one week interval between each subject. The total number of subjects will be 50 since 5 different plant essential oils will be administered to 10 subjects, and the total number of sessions will be doubled with and without plant essential oils to 100 sessions.
Phase 2
The Uchida-Kraepelin test will be used to determine the effect of the presence or absence of mild stress. The presence or absence of the Uchida-Kraepelin test will be added. One subject will be treated twice, one week apart. The total number of subjects will be 50 and the total number of treatments will be 200.
Phase 3
The effects of daily treatments will be examined. The Uchida-Kraepelin test will be used to determine the effect of the presence or absence of mild stress. The presence or absence of the Uchida-Kraepelin test will be added. One subject will be treated on consecutive days. The total number of subjects will be 50 and the total number of treatments will be 200.
Key secondary outcomes
Blood pressure and heart rate will be measured to determine the subject's condition before and after the treatment.
A questionnaire will be administered to the subjects regarding their age, height, weight, allergies, likes/dislikes of various essential oil scents, and current state of relaxation to determine their relationship to the effects of the treatment on the autonomic nervous system.
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The effects of the presence and absence of essential plant oils and the effects of different types of essential plant oils will be conducted twice with one week interval between each subject. The total number of subjects will be 50 since 5 different plant essential oils will be administered to 10 subjects, and the total number of sessions will be doubled with and without plant essential oils to 100 sessions.
Interventions/Control_2
Phase 2
The Uchida-Kraepelin test will be used to determine the effect of the presence or absence of mild stress. The presence or absence of the Uchida-Kraepelin test will be added. One subject will be treated twice, one week apart. The total number of subjects will be 50 and the total number of treatments will be 200.
Interventions/Control_3
The effects of daily treatments will be examined. The Uchida-Kraepelin test will be used to determine the effect of the presence or absence of mild stress. The presence or absence of the Uchida-Kraepelin test will be added. One subject will be treated on consecutive days. The total number of subjects will be 50 and the total number of treatments will be 200.
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
Student volunteers from International University of Health and Welfare
Total number of volunteers, 50 men and 50 women, 100 people in total (some duplication of subjects may occur due to different types of plant essential oils)
Key exclusion criteria
Students with any underlying medical condition
Target sample size
100
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
Department of 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
Department of 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
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
2600-1 Kitakanemaru, Ohtawara, Tochigi
Tel
0287-24-3125
s-rinri@iuhw.ac.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 | 02 | Month | 07 | 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
50
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
Terminated
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 07 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056735
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