UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015351
Receipt number R000017858
Scientific Title The test of the effect for eyestrain of the Bilberry extracts
Date of disclosure of the study information 2014/10/06
Last modified on 2015/02/09 17:20:45

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Basic information

Public title

The 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 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

Not applicable

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

Key secondary outcomes

Pulsatile ocular blood flow
Visual analog scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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(4 weeks)

Interventions/Control_2

Placebo(4 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Aged=>20 years,Male and female
Subjects who are aware of eyestrain.
Subjects who do not have the LASIK.
Subjects who do not regular use reading glasses.

Key exclusion criteria

1)Subjects who have previous medical history of drug and/or food allergy.
2)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., diabetes, digestive organ, liver, pancreas, heart and/or kidney).
3)Subjects who have been enrolled in the other clinical trials within about last 1 month.
4)Subjects who predicted gluttony and irregular eating habits by the pre-questionnaire and doctor's questions.
5)Subjects who constantly use supplements and/or functional foods affecting eyestrain.
6)Subjects who take medicines and plan to take new health foods.
7)Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

30


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

Email

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


Email

kosehira@omnica.co.jp


Sponsor or person

Institute

Universal Clinical Systems Co., Ltd.

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


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

葉山眼科クリニック


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 06 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

2014 Year 10 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 07 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

2014 Year 10 Month 06 Day

Last modified on

2015 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name