UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035953 |
|---|---|
| Receipt number | R000040907 |
| Scientific Title | The Effect of Eucalyptol on Nursing Home Residents |
| Date of disclosure of the study information | 2019/02/21 |
| Last modified on | 2019/02/20 13:51:28 |
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Basic information
Public title
The Effect of Eucalyptol on Nursing Home Residents
Acronym
Eucalyptol Scent
Scientific Title
The Effect of Eucalyptol on Nursing Home Residents
Scientific Title:Acronym
Eucalyptol Scent
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study whether eucalyptol aroma is an effectiveness at reducing the symptoms of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
MMSE, DBD, CMAI
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 78 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
residence of the nursing home
Key exclusion criteria
no medication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiko Goto |
Organization
Nagasaki University
Division name
School of Environmental Science
Zip code
Address
1-14 Bunkyo-machi Nagasaki-shi Nagasaki
TEL
095-894-2740
gotos@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Goto |
Organization
Nagasaki University
Division name
School of Environmental Science
Zip code
Address
1-14 Bunkyo-machi Nagasaki-shi Nagasaki
TEL
095-894-2740
Homepage URL
gotos@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 02 | Month | 21 | 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
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two one-week single blind experiments were conducted between 6/18-6/24/2018, and 10/12-10/18/2018, approximately 4 months apart. Before and after each test, subjects and controls were tested using the MMSE (Mini-Mental State Examination), DBD (Dementia Behavior Disturbance scale), and CMAI (Cohen-Mansfield Agitation Inventory) (6/8-6/17, 6/25-7/3, 10/2-10/11, 10/19-10/25). During the second experiment, caregivers gave a simple memory test to the subject group. Follow-up DBD, CMAI, and MMSE tests were conducted for the control group three weeks after the second experiment (11/6).
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040907
