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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vidya herbs
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Changes in visual capacity evaluated by standard comprehensive ophthalmic examination (Snellen test).
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Males & Females with age 30–60 year •Subjects able to provide informed consent.
- •â€¢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.
排除标准
- •â€¢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.
- •â€¢Subject has been clinically diagnosed with cataracts in the study eye.
- •â€¢Subject has had a fluorescence angiogram within the last six months.
- •â€¢Pregnant or lactating women •Subject has undergone a treatment using photodynamic drugs within the last year.
- •â€¢Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
- •â€¢Subject was fit with contact lens within the last 30 days.
结局指标
主要结局
•Changes in visual capacity evaluated by standard comprehensive ophthalmic examination (Snellen test).
时间窗: Screening to EOT (Day 90)
•Changes in eye conditions like Eye strain / redness / watering / burning sensation / itching in the eye.
时间窗: Screening to EOT (Day 90)
次要结局
- • Incidence and rate of adverse events(Screening to EOT (Day 90))