UMIN-CTR Clinical Trial

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
Email	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
Email	takashi.itokawa@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045554