UMIN-CTR Clinical Trial

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
Email	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
Email	kubo@kumamoto-hsu.ac.jp

Sponsor
Institute	Kumamoto Health Science University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047838