UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039951 |
|---|---|
| Receipt number | R000045554 |
| Scientific Title | Effect of ocular surface temperature and blood flow in oral cavity stimulation and warmed compress |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2020/03/26 13:42:04 |
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Basic information
Public title
Effect of ocular surface temperature and blood flow in oral cavity stimulation and warmed compress
Acronym
Effect of ocular surface temperature and blood flow after stimulation
Scientific Title
Effect of ocular surface temperature and blood flow in oral cavity stimulation and warmed compress
Scientific Title:Acronym
Effect of ocular surface temperature and blood flow after stimulation
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The blood flow and temperature were evaluated in various systemic disease. Moreover in the disease location blood flow was associated with temperature. However, no study has reported the relationship between blood flow and temperature at the same location in ocular anterior segment. the purpose of this study was to investigate the relationship between blood flow and temperature in ocular anterior segment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in temperature and blood flow after oral cavity stimulation and warm compress
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
experimental 1
warm comperss
Interventions/Control_2
experimental 2
capsaicin solution
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
normal subjects
Key exclusion criteria
ocular disease
systemic cisease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Itokawa |
Organization
Toho university medical center
Division name
Ophthalmology
Zip code
143-8541
Address
6-11-1 Omori Nishi Ota-ku, Tokyo
TEL
03-3761-4151
takashi.itokawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Itokawa |
Organization
Toho university medical center
Division name
Ophthalmology
Zip code
143-8541
Address
6-11-1 Omori Nishi Ota-ku, Tokyo
TEL
03-3761-4151
Homepage URL
takashi.itokawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho 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
Toho university medical center
Address
6-11-1 Omori Nishi Ota-ku, Tokyo
Tel
03-3761-4151
takashi.itokawa@med.toho-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | 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
60
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 | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045554
