UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061517 |
|---|---|
| Receipt number | R000070386 |
| Scientific Title | The Effects of Aromatic Stimulation from Essential Oils on the Physiological Functions and Psychological State of Women in Menopause |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/11 11:28:17 |
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Basic information
Public title
The Effects of Aromatic Stimulation from Essential Oils on the Physiological Functions and Psychological State of Women in Menopause
Acronym
Research on Alpinia speciosa Essential Oil
Scientific Title
The Effects of Aromatic Stimulation from Essential Oils on the Physiological Functions and Psychological State of Women in Menopause
Scientific Title:Acronym
Research on Alpinia speciosa Essential Oil
Region
| Japan |
Condition
Condition
Menopausal symptoms
Classification by specialty
| Endocrinology and Metabolism | Neurology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effectiveness of aromatic stimulation using essential oils in women going through menopause and scientifically clarify the role that olfactory stimulation can play in promoting physical and mental well-being during this stage of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep quality, relief of menopausal symptoms
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Alpinia zerumbet essential oil will be used to provide aromatic stimulation via a diffuser in the participants bedrooms. The intervention period will last four weeks, with aromatic exposure administered daily at bedtime.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Menopausal women
Key exclusion criteria
People with allergies to essential oils
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Sakuma |
Organization
Chubu University
Division name
School of Applied Biological Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai City, Aichi Prefecture
TEL
0568-51-8925
sakuma@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Sakuma |
Organization
Chubu University
Division name
School of Applied Biological Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai City, Aichi Prefecture
TEL
0568-51-8925
Homepage URL
sakuma@fsc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu University
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
Ethics Committee of Chubu University
Address
1200 Matsumoto, Kasugai, Aichi
Tel
0568-51-4424
info-gakuji@fsc.chubu.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
| 2026 | Year | 05 | Month | 11 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070386
