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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035322
Receipt No. R000040248
Scientific Title Investigation of the effectiveness of aromatherapy using tea tree oil for dementia patients
Date of disclosure of the study information 2019/04/01
Last modified on 2020/02/05

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Basic information
Public title Investigation of the effectiveness of aromatherapy using tea tree oil for dementia patients
Acronym Investigation of the effectiveness of aromatherapy using tea tree oil for dementia patients
Scientific Title Investigation of the effectiveness of aromatherapy using tea tree oil for dementia patients
Scientific Title:Acronym Investigation of the effectiveness of aromatherapy using tea tree oil for dementia patients
Region
Japan

Condition
Condition Alzheimer's disease and Lewy body dementia
Classification by specialty
Neurology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of long-term aromatherapy using tea tree oil on cognitive function and BPSD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mini Mental State Examination(MMSE)
Key secondary outcomes Clock Drawing Test(CDT)
Word Fluency Test(WFT)
NPI-Brief Questionnaire Form(NPI-Q)
Modified the Crichton Geriatric Behavioural Rating Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The subject performs aromatherapy using tea tree oil for 4 weeks every day.
A piece of tissue paper which contains several drops of tea tree oil is set around the subject's pillow between 18:00 and 20:00 before the subject goes to bed.
The piece of tissue paper is collected on the following morning.
Interventions/Control_2 The subject performs aromatherapy using jojoba oil for 4 weeks every day.
A piece of tissue paper which contains several drops of jojoba oil is set around the subject's pillow between 18:00 and 20:00 before the subject goes to bed.
The piece of tissue paper is collected on the following morning.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Dementia patients (Alzheimer's disease or Lewy body dementia) and patients with MCI
2.Patients who score 20 points or more on MMSE
3.Patients who live together with family members
Key exclusion criteria 1.Patients whose sense of smell is reduced
2.Patients who have sensitive skin
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Ayae
Middle name
Last name Kinoshita
Organization Graduate School of Medicine Kyoto university
Division name Human Health Sciences
Zip code 606-8397
Address 53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-4300
Email kinoshita.ayae.6v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hinako
Middle name
Last name Tanaka
Organization Graduate School of Medicine Kyoto university
Division name Human Health Sciences
Zip code 606-8397
Address 53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-4300
Homepage URL
Email tanaka.hinako.75n@st.kyoto-u.ac.jp

Sponsor
Institute Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshida-konoe-cho, Sakyo-ku, Kyoto, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2019 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 12
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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 20 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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