UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041918 |
|---|---|
| Receipt number | R000047838 |
| Scientific Title | Analysis of the effect of the use of essential oil (1,8-cineole) -containing bath additives on cognitive function in the elderly |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2021/04/01 11:42:11 |
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Basic information
Public title
Effects of bath additives containing essential oils on cognitive function in the elderly
Acronym
Effects of bath additives on cognitive function in the elderly
Scientific Title
Analysis of the effect of the use of essential oil (1,8-cineole) -containing bath additives on cognitive function in the elderly
Scientific Title:Acronym
Effects of the use of essential oil-containing bath additives on cognitive function in the elderly
Region
| Japan |
Condition
Condition
General elderly and MCI elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effects of bathtub habits using essential oil (1,8-cineole) -containing bath additives on cognitive function and QOL of the elderly and MCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Montreal Cognitive Assessment(MoCA-J):Evaluation will be conducted at the start, after 4 and 8 weeks
Key secondary outcomes
Dementia Quality of Life Instrument Japanese version,The Japanese Mild Cognitive Impairment screen
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Bathing with unscented bath additive(39-40 degrees Celsius, 15 minutes once),63 days
Interventions/Control_2
Bathing with a bath additive containing essential oil (1,8-cineole;Exposure concentration does not exceed about 0.2 ppm)(39-40 degrees Celsius, 15 minutes once),63 days
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
General group: Elderly people at home with a MoCA-J score of 26 or higher, with no history of sinusitis or chronic illness.
MCI group: Elderly people at home with a MoCA-J score of 25 or less who have no history of sinusitis or chronic illness.
Key exclusion criteria
Those who are sensitive to essential oils (1,8-cineole), those who dislike it, or those who have allergic reactions to aroma oils in the past.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Iiyama |
| Middle name | |
| Last name | Jun-ichi |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumimachi, Kita-ku, Kumamoto
TEL
096-275-2111
iiyama@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Kubo |
| Middle name | |
| Last name | Takaaki |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumimachi, Kita-ku, Kumamoto
TEL
096-275-2111
Homepage URL
kubo@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Bathclin Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto Health Science University
Address
Faculty of Health Sciences
Tel
096-275-2111
kubo@kumamoto-hsu.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 | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047838
