UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047325 |
|---|---|
| Receipt number | R000053978 |
| Scientific Title | Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/08/18 17:24:33 |
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Basic information
Public title
Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Acronym
Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Scientific Title
Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Scientific Title:Acronym
Effects of Olfactory stimulation with Essential oils on Cognitive Function in elderly
Region
| Japan |
Condition
Condition
Non specific
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of continuous olfactory stimulation with essential oil on cognitive function, olfactory function, QOL, feeling and emotion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The scales of cognitive function and olfaction at 4 weeks after intervention started
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Aromatherapy using yuzu, hinoki, lavender essential oil
Interventions/Control_2
Aromatherapy using water
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
| 65 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Those who are not suspected case of dementia
2.Those who are not suspected case of olfactory dysfunction
3.Those who have been obtained written consent
Key exclusion criteria
1.With diseases that interrupt carrying out this study, such as malignant tumors,cardiac insufficiency, hepatic disorder, renal disorder,
endocrine disease, diabetes, nutrition disorder, alcoholic, grave pulsus irregularis,and Parkinson disease
2.Taking medicine of central nerve system
3.Those who have been affected with disease of cranial nervous system and psychiatric disorder
4.Being tend to depression
5.Visiting hospital because of decline of cognitive function
6.Taking medicine or supplement in order to improve cognitive function
7.Being Certificated of Needed Long-Term Care or Needed Support
8.Those who have been undergone an operation on nose, taking Tokishakuyakusan, Ninzinneiyoutou, or steroid hormones
9.With eye diseases such as glaucoma, grave decline of eyesight, and blepharoptosis
10.With Meniere disease
11.Being prohibited participating in this study by doctors
12.Have allergies to fragrance or cosmetics
13.Don't like scent of yuzu,hinoki, and lavender
14.Have plans of surgery or trip during intervention
15.Smoker
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Chizu |
| Middle name | |
| Last name | Kumagai |
Organization
Aroma Environment Association of Japan
Division name
Chairman of The Board of Directors
Zip code
151-0051
Address
5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
TEL
03-6384-2861
research@aromakankyo.or.jp
Public contact
Name of contact person
| 1st name | Chiho |
| Middle name | |
| Last name | Muto |
Organization
Aroma Environment Association of Japan
Division name
Academic Research Division
Zip code
151-0051
Address
5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
TEL
03-6384-2861
Homepage URL
research@aromakankyo.or.jp
Sponsor or person
Institute
Aroma Environment Association of Japan
Institute
Department
Personal name
Funding Source
Organization
Aroma Environment Association of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aroma Environment Association of Japan
Address
5-21-12-7F, Sendagaya, Shibuya-ku, Tokyo
Tel
03-6384-2861
research@aromakankyo.or.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
| 2022 | 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
33
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 | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053978
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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