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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024204
Receipt No. R000027466
Scientific Title A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of Bilberry extract capsules (180mg) in the eye health of human adults.
Date of disclosure of the study information 2016/09/28
Last modified on 2016/09/28

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Basic information
Public title A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of Bilberry extract capsules (180mg) in the eye health of human adults.
Acronym A clinical study to evaluate the efficacy and safety of Bilberry extract capsules in the eye health of human adults.
Scientific Title A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of Bilberry extract capsules (180mg) in the eye health of human adults.
Scientific Title:Acronym A clinical study to evaluate the efficacy and safety of Bilberry extract capsules in the eye health of human adults.
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 To assess the efficacy of European Bilberry extract (Bilcyan) in eye health of human adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in visual capacity evaluated by standard comprehensive ophthalmic examination(Snellen test) before and after ingestion(12 weeks)
Changes in eye conditions like Eye strain/redness/watering/burning sensation/itching in the eye before and after ingestion(12 weeks)
Key secondary outcomes Incidence and rate of adverse events after ingestion(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 One Bilberry extract(Bilcyan) capsule(180mg) twice a day (before breakfast and dinner) for 12 weeks
Interventions/Control_2 One placebo capsule twice a day (before breakfast and dinner) 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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1)Males and females with age 30-60year
2)Subjects who are able to provide informed consent
3)Patients willing and able to comply with all trial requirements
4)Subjects having at least anyone of the following condition; Eye strain/redness/watering/burning sensation/itching in the eyes/acuity of vision
Key exclusion criteria 1)Subject having the crystalline lens removed from the study eye or the crystalline lens removed and replaced with an intraocular lens(IOL) implant in the left eye
2)Subject clinically diagnosed with cataracts in the study eye
3)Subject having a fluorescence angiogram within the last six months
4)Pregnant or lactating women
5)Subject undergone a treatment using photodynamic drugs within the last year
6)Subject having Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam
7)Subject fit with contact lens within the last 30 days
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. H. N. Sowbhagya
Organization Kempegowda Institute of Medical Sciences
Division name Department of Ophthalmology
Zip code
Address K.R. Road, Bangalore - 560004
TEL 91-80-26712791
Email bngkims@kar.nic.in

Public contact
Name of contact person
1st name
Middle name
Last name Momoko Imai
Organization Vidya Japan K.K.
Division name Sales
Zip code
Address Sai Bldg.6F, 3-1-22, Nishiazabu, Minato-ku, Tokyo
TEL 03-6721-0430
Homepage URL
Email m-imai@vidyajapan.co.jp

Sponsor
Institute Vidya Herbs Pvt Ltd.
Institute
Department

Funding Source
Organization Vidya Herbs Pvt 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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 28 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 1)Throughout the clinical study time period there is no adverse effects were found in clinical study subjects so it can be conclude that the investigational products are safe to use.
2)The case registered for this trial group-A(Bilberry extract 180mg capsules) showed significant improvement in quality of life, eye vision and in reducing the symptoms of eye conditions like eye redness/itching/eye watering/eye burning sensation/strain and acute vision in the healthy adults. It can be said that eye health conditions like eye redness/itching/eye burning sensation/strain and acute vision was well controlled by Bilberry extract(180mg) capsules when compare with the placebo.
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
2015 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2016 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027466

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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