UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053271 |
|---|---|
| Receipt number | R000060177 |
| Scientific Title | Research on the swallowing function improvement effect of inhalation of cypress essential oil |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/01/05 14:15:59 |
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Basic information
Public title
Research on the swallowing function improvement effect of inhalation of cypress essential oil
Acronym
Swallowing function improvement effect by inhaling cypress essential oil
Scientific Title
Research on the swallowing function improvement effect of inhalation of cypress essential oil
Scientific Title:Acronym
Swallowing function improvement effect by inhaling cypress essential oil
Region
| Japan |
Condition
Condition
Swallowing dysfunction
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the immediate effects of inhalation of cypress essential oil on swallowing function in elderly people with impaired swallowing function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
RSST
Key secondary outcomes
MWST
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hinoki essential oil inhalation
Interventions/Control_2
Rice oil
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
Revised Hasegawa Simple Intelligence Scale (HDS-R) or Mini-Mental State (MMSE) score of 15 or higher
Key exclusion criteria
15 points or less on the Revised Hasegawa Simple Intelligence Scale (HDS-R) or Mini-Mental State Examination (MMSE)
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Qing |
| Middle name | |
| Last name | Li |
Organization
Nippon Medical School Hospital
Division name
Department of Rehabilitation Medicine
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
08041151962
qing-li@nms.ac.jp
Public contact
Name of contact person
| 1st name | Qing |
| Middle name | |
| Last name | Li |
Organization
Nippon Medical School Hospital
Division name
Department of Rehabilitation Medicine
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
08041151962
Homepage URL
qing-li@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Qing Li
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Misato Care Center
Address
260-2 Minamihasunuma, Misato, Saitama prefecture
Tel
048-953-6161
qing-li@nms.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
| 2024 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
in preparation
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060177
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
