UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035322 |
|---|---|
| Receipt number | 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 16:14:09 |
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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
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
tanaka.hinako.75n@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040248
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