UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020866 |
|---|---|
| Receipt number | R000024082 |
| Scientific Title | The randomized duble blind parallel-group comparison test of the effect for eyestrain of the Bilberry extracts |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2017/02/03 09:59:22 |
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Basic information
Public title
The randomized duble blind parallel-group comparison test of the effect for eyestrain of the Bilberry extracts
Acronym
The test of the effect for eyestrain of the Bilberry extracts
Scientific Title
The randomized duble blind parallel-group comparison test of the effect for eyestrain of the Bilberry extracts
Scientific Title:Acronym
The test of the effect for eyestrain of the Bilberry extracts
Region
| Japan |
Condition
Condition
eyestrain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficiency for eyestrain of the foods including bilberry extracts
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Near-reflex: intake 0,4,8,12 weeks
Key secondary outcomes
Subjective symptoms: intake 0, 2, 4, 6, 8, 10, 12 weeks
Eyestrain questionnaires: intake 0, 4, 8, 12 weeks
Safety(blood test, urinary test, history taking):intake 0, 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Bilberry extract 240mg/day, 12weeks
Interventions/Control_2
Placebo, 12weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Aged=>20 years,Male and female
2, Japanese male and female
3, PC work or driving 5 hours or more a day
4, Visual acuity with the naked eyes is 0.1 or more
Key exclusion criteria
1, Subjects who have previous medical history and/or current medical history of serious diseases (e.g., digestive organ, liver, pancreas, heart and/or kidney).
2, Subjects who take medicines.
3, Subjects who have an eye disease.
4, Subjects who have previous medical history of drug and/or food allergy.
5, Subjects who have previous medical history and/or current medical history of drug dependence and/or drug abuse.
6, Subjects who work time is irregular.
7, Subjects who have undergone LASIK.
8, Subjects who are using the reading glasses.
9, Subjects who constantly use supplements containing bilberry extract and/or functional foods or drug affecting eyestrain.
10, Subjects who have been enrolled in the other clinical trials within about last 1 month.
11, Subjects who is during pregnancy, lactation and/or wish to become pregnant in clinical test.
12, Subjects who have taken over 200 mL of blood within the last one month prior to the current study.
13, Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marie Kosehira |
Organization
Omnica Co.,Ltd
Division name
Research team
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9811
kosehira@omnica.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marie Kosehira |
Organization
Omnica Co.,Ltd
Division name
Research team
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9811
Homepage URL
kosehira@omnica.co.jp
Sponsor or person
Institute
HUMA R&D Co.
Institute
Department
Personal name
Funding Source
Organization
Omnica Co.,Ltd
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
| 2016 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | 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
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024082
