UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024204 |
|---|---|
| Receipt number | 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 15:27:18 |
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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
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
m-imai@vidyajapan.co.jp
Sponsor or person
Institute
Vidya Herbs Pvt Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027466
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
