UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039796 |
|---|---|
| Receipt number | R000044634 |
| Scientific Title | Evaluation of the effect of olfactory training on cognitive function in healthy adults. |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2022/03/14 14:14:13 |
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Basic information
Public title
Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Acronym
Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Scientific Title
Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Scientific Title:Acronym
Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Region
| Japan |
Condition
Condition
Cognitive dysfunction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of olfactory training with aromatherapy on memory function in healthy elderly subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
memory function ( a 24-week period)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
essential oil (rose odor, eucalyptus odor, lemon odor, and cloves odor)
Interventions/Control_2
essential oil (rosemary odor, lavender odor, lemon odor, and orange odor)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
60 years or older
Key exclusion criteria
subjects who were diagnosed with dementia and receiving treatment
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | SACHIKO |
| Middle name | TANAKA |
| Last name | TANAKA |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Clinical Pharmacology
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
TEL
0426765796
sachiko@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | SACHIKO |
| Middle name | TANAKA |
| Last name | TANAKA |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Clinical Pharmacology
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
TEL
0426765796
Homepage URL
sachiko@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Pharmacy and Life Sciences
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
Tokyo University of Pharmacy and Life Sciences
Address
1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
Tel
0426765111
sakurai@toyaku.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
| 2020 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044634
