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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024872
Receipt No. R000028595
Scientific Title Effect of bilberry extract supplement on eye conditions and functions: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2016/11/18
Last modified on 2017/04/17

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Basic information
Public title Effect of bilberry extract supplement on eye conditions and functions: a double-blind, randomized placebo-controlled and parallel study
Acronym Effect of bilberry extract supplement on eye conditions and functions
Scientific Title Effect of bilberry extract supplement on eye conditions and functions: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym Effect of bilberry extract supplement on eye conditions and functions
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the effect of bilberry extract supplement on eye conditions and functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Subjective evaluation
(at week 0,4,8,12)Perform the test before and after work for 70 minutes
Key secondary outcomes 1.Fliker test
2.Accommodative fanction
1~2:(at week 0,4,8,12)Perform the test before and after work for 70 minutes

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 Prevention
Type of intervention
Food
Interventions/Control_1 Ingest 200 mg bilberry extract soft capsules (1 grain per day for 12 weeks)
Interventions/Control_2 Ingest placebo soft capsules (1 grain per day for 12 weeks)
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
30 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects who are aware of temporary eye fatigue
2.Adult male and female not suffering from a disease that affects the test
3.Subjects who perform VDT operation on a regular basis
Key exclusion criteria 1. Subjects with hay fever
2. Subjects with food allergies
3. Subjects who are pregnant or lactating
4. Subjects who consume medicinal product which may influence the outcome of the study
5.Subjects who consume food which may influence the outcome of the study
6. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan clinical trial assosiation
Division name N.A.
Zip code
Address 8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL 03-6457-4666
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Kojima
Organization Japan clinical trial association
Division name N.A.
Zip code
Address 8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL 03-6457-4666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial association
Institute
Department

Funding Source
Organization YAWATA CORPORATION
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
Email

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 11 Month 18 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 11 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 18 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 11 Month 17 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028595

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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