UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012474 |
|---|---|
| Receipt number | R000014588 |
| Scientific Title | The application of water-dispersible hesperetin to the retina as a drug which improves retinal circulation |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2013/12/03 16:20:46 |
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Basic information
Public title
The application of water-dispersible hesperetin to the retina as a drug which improves retinal circulation
Acronym
Water-disopersible hesperetin in the retinal diseases
Scientific Title
The application of water-dispersible hesperetin to the retina as a drug which improves retinal circulation
Scientific Title:Acronym
Water-disopersible hesperetin in the retinal diseases
Region
| Japan |
Condition
Condition
Diabetic Retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether water-dispersible hesperetin can increase the retinal blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the diameter, velocity and blood flow of retinal vessels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The administration of 200mg of water-dispersible hesperetin for 7 days
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Men who don't have any past history of diseases
Older than or equal to 20 years old and younger than or equal 30 to years old.
Subject who provide us informed consent after they make comprehension of the purpose of this study.
Key exclusion criteria
Subjects who take a medicine
Subjects who have past history of eye diseases
Subjects who smoke more than 20 cigarettes
Subjects who are alcoholic
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harumasa Yokota |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
2-1-1-1 Midorigaoka HIgashi, Asahiawa, Hokkaido, JAPAN
TEL
0166-68-2543
atokoy18@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Harumasa Yokota |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
2-1-1-1 Midorigaoka HIgashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2543
Homepage URL
atokoy18@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Company, Limited
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
| 2013 | Year | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | 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
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2013 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014588
