| CTRI Number |
CTRI/2016/05/006976 [Registered on: 31/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy and safety of bilberries extract capsules (180mg) in the eye health of human adults. |
|
Scientific Title of Study
|
A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of bilberries extract capsules (180mg) in the eye health of human adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/VH/0529/53, Version 01 dated 29-May-2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H N Sowbhagya MBBS MS Ophthalmology |
| Designation |
Ophthalmologist Professor, HOD |
| Affiliation |
K.I.M.S Hospital and Research Centre |
| Address |
Department of Ophthalmology
Kempegowda Institute of Medical Sciences
K.R. Road, Bangalore – 560004
Bangalore
KARNATAKA
Bangalore – 560004
India |
| Phone |
9620937759 |
| Fax |
|
| Email |
drhnsowbhagyaappaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical Research Pvt. Ltd.
#16, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
Bangalore
KARNATAKA
Bangalore - 560097
India |
| Phone |
9900111997 |
| Fax |
08023641033 |
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
ICBio Clinical Research Pvt. Ltd.
#16, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
Bangalore
KARNATAKA
Bangalore - 560097
India |
| Phone |
9900111997 |
| Fax |
08023641033 |
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vidya herbs |
| Address |
Vidya Herbs
#30, 33rd Main,
J P Nagar 6th Phase,
Bangalore 560078, India.
|
| Type of Sponsor |
Other [( Herbal Company )] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr HN Sowbhagya |
K.I.M.S hospital and research centre |
Department of Ophthalmology
Kempegowda Institute of Medical Sciences
K.R. Road, Bangalore – 560004
Bangalore
KARNATAKA |
9620937759
drhnsowbhagyaappaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H119||Unspecified disorder of conjunctiva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilberry Extract Capsules |
Orally in sitting posture, one capsule in each day before breakfast and dinner for 90 days. |
| Comparator Agent |
Placebo capsules |
Orally in sitting posture, one capsule in each day before breakfast and dinner for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Males & Females with age 30–60 year
•Subjects able to provide informed consent.
•Patient is willing and able to comply with all trial requirements
•Subjects is having at least anyone of the following condition- Eye strain / redness / watering / burning sensation / itching in the eyes / acuity of vision.
|
|
| ExclusionCriteria |
| Details |
•Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
•Subject has been clinically diagnosed with cataracts in the study eye.
•Subject has had a fluorescence angiogram within the last six months.
•Pregnant or lactating women
•Subject has undergone a treatment using photodynamic drugs within the last year.
•Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
•Subject was fit with contact lens within the last 30 days.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Changes in visual capacity evaluated by standard comprehensive ophthalmic examination (Snellen test).
•Changes in eye conditions like Eye strain / redness / watering / burning sensation / itching in the eye.
|
Screening to EOT (Day 90)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Incidence and rate of adverse events |
Screening to EOT (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
21/06/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective ,Randomized,double blind ,Placebo controlled Clinical study to evaluate the efficacy and safety of bilberries extract capsules ( 180 mg) in the eye health of human adults.
Primary objective:- To evaluate the efficacy of bilberry extract in eye health of human adults
Secondary objective To evaluate the safety of bilberry extract in eye health of human adults
A total of 30 subject would be enrolled for the study .
Bilberry capsules to be taken twice daily one in the morning and one in the evening
The data will be analyzed with 5% significance level and 80% power for study using SAS. the difference within the group will be assessed using paired T test and between the group will be assessed using independent T test .
|