CTRI/2019/05/019392已完成Phase 3 4
A Prospective, Double Blind, Randomized, Placebo Controlled Interventional Study, to evaluate Safety and Efficacy of Centella Asiatica Extract tablets in Improving MPOD Levels in Elderly Volunteers.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Macular pigment optical density measurement
研究概览
简要总结
Mechanism to improve eye health by Centella asiatica (CA) has not been studied, therefore we performed this experiment for the first time. We investigated the effects of CAE50, asiaticoside and asiatic acid, which are active ingredients, on the inhibition of retinal cell injury in vitro.. the primary objective of this study is to evaluate the safety and efficacy of centella asiatica extract tablets in improving MPOD levels in elderly volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a.Volunteers of either sex, between 45 to 65 years of age.
- •b.Volunteers with MPOD level between 0.2 – 0.4 c.Volunteers having no clinically significant ocular pathological condition, but clinically non-significant problem with accommodation of the eye can be included.
- •d.Able to abide the dietary regime mentioned in the protocol e.Willing to come for regular follow –up visits.
- •f.Able to give written informed consent.
排除标准
- •a.Known history of hypersensitivity to herbal extracts or dietary supplements.
- •b.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc.
- •will be excluded.
- •c.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
- •d.On-going treatment with herbals or allopathic ocular drugs.
- •e.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
- •f.Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study.
结局指标
主要结局
Macular pigment optical density measurement
时间窗: Day 0,Day 60, Day 120 and Day 180
次要结局
- Safety parameters like Vitals,Liver function tests,Haematology and 4.Renal Function Tests(Day 0 and Day 120)
研究者
研究点 (1)
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