UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027693 |
|---|---|
| Receipt number | R000031722 |
| Scientific Title | Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from natural green tea leaf |
| Date of disclosure of the study information | 2017/06/19 |
| Last modified on | 2019/03/04 09:10:55 |
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Basic information
Public title
Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from natural green tea leaf
Acronym
Examination of the aromatherapy using the essential oil which was extracted from natural green tea leaf
Scientific Title
Examination of the influence for cognitive function of aromatherapy using the essential oil which was extracted from natural green tea leaf
Scientific Title:Acronym
Examination of the aromatherapy using the essential oil which was extracted from natural green tea leaf
Region
| Japan |
Condition
Condition
Alzheimer's disease, mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether aromatherapy using the essential oil which was extracted from natural green tea leaf affects for cognitive function in Alzheimer's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of Touch Panel-type Dementia Assessment Scale (TDAS) after four weeks
Key secondary outcomes
The results of questionnaire after four weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In before and after that subjects perform aromatherapy using aroma pendant in the morning, we carry out tests of cognitive function and questionnaires. Subjects carry out the aromatherapy for two hours a day and continue for four weeks.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are more than 40 years old at the time of registration
2) Alzheimer's disease patients who fulfill of the DSM-5 and NINCDS-ADRDA criteria, or mild cognitive impairment patients who fulfill of the Petersen criteria.
3) The consent from proxies is necessary.
4) If the patient use antidementia medicine, it is necessary that cognitive function is stable
Key exclusion criteria
1) Subjects who have a serious allergic disease
2) Subjects who are diagnosed olfactory disturbance
3) Subjects who have a serious heart disease
4) Subjects who have the past of epilepsy
5) Subjects who are conducting other aromatherapy during the intervention period
6) Pregnant women
7) Subjects who are assessed by the principal investigator due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Urakami |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6354
kurakami@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kouzuki |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6358
Homepage URL
kouzuki@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
ACT-FO Co., Ltd.
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
Address
Tel
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
| 2017 | Year | 06 | Month | 19 | 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
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031722
