UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015253 |
|---|---|
| Receipt number | R000017715 |
| Scientific Title | The randomized duble blind parallel-group comparison test of the effect for eyestrain of the functional food including Bilberry extracts |
| Date of disclosure of the study information | 2014/09/26 |
| Last modified on | 2017/02/28 18:18:14 |
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Basic information
Public title
The randomized duble blind parallel-group comparison test of the effect for eyestrain of the functional food including Bilberry extracts
Acronym
The test of the effect for eyestrain of the functional food including Bilberry extracts
Scientific Title
The randomized duble blind parallel-group comparison test of the effect for eyestrain of the functional food including Bilberry extracts
Scientific Title:Acronym
The test of the effect for eyestrain of the functional food including Bilberry extracts
Region
| Japan |
Condition
Condition
Eyestrain
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy of the foods including bilberry extracts for eyestrain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Near-reflex
Key secondary outcomes
Dry eye test, Fundus blood flow speed, Visual analog scale, Physical examinations, Blood test, Urine test and adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
control group
Interventions/Control_2
test sample1 group
Interventions/Control_3
test sample2 group
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who are aware of eyestrain.
Subjects who ageree to participate in the current study with written informed consent.
Key exclusion criteria
Subjects who have serious historical disease of ophhalmopathy or have morbidity.
Subjects who daily ingest drugs or health foods which would improve eyestrain.
Subjects who have serious historical disease or have morbidity, marked impairment of heart, lung,liver, kidney, heart, or gastrointestinal tract functions (excluding extirpation of vermiform appendix).
Subjects suspected that accommodative asthenopia or other non-neurogenic.
Pregnant and lactating female, or who wish to get pregnant during the study period.
Subjects who participate in other clinical trials within the last 4 weeks prior to the current clinical trial.
Subjects who are ineligible due to physician's judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kitaichi Nobuyoshi |
Organization
Health Sciences University of Hokkaido Hospital
Division name
Department of Ophthalmology
Zip code
Address
Ainosato2-5, Kita-ku, Sapporo, Japan
TEL
011-775-7878
nobukita@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Shimpei |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Department of Ophthalmology , Health Sciences University of Hokkaido Hospital
Institute
Department
Personal name
Funding Source
Organization
OMNICA Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
北海道医療大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017715
