A Clinical study to evaluate the efficacy and safety of bilberries extract capsules (180mg) in the eye health of human adults.
- Conditions
- Unspecified disorder of conjunctiva,
- Registration Number
- CTRI/2016/05/006976
- Lead Sponsor
- Vidya herbs
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- •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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Changes in visual capacity evaluated by standard comprehensive ophthalmic examination (Snellen test). Screening to EOT (Day 90) •Changes in eye conditions like Eye strain / redness / watering / burning sensation / itching in the eye. Screening to EOT (Day 90)
- Secondary Outcome Measures
Name Time Method • Incidence and rate of adverse events Screening to EOT (Day 90)
Trial Locations
- Locations (1)
K.I.M.S hospital and research centre
🇮🇳Bangalore, KARNATAKA, India
K.I.M.S hospital and research centre🇮🇳Bangalore, KARNATAKA, IndiaDr HN SowbhagyaPrincipal investigator9620937759drhnsowbhagyaappaji@gmail.com