A randomized, double blind, placebo controlled, parallel study to evaluate the comparative efficacy of XanMax® 2002 oral soft gel capsule with that of a placebo soft gel capsule in improving MPOD levels in elderly volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Macular pigment density measurement
研究概览
简要总结
Elderly volunteers whose MPOD values are between 0.2 and 0.4 will be enrolled into the study after obtaining Institutional Ethics Committee approved Informed Consent, in writing. All 60 subjects will receive either placebo or active product in the ratio of 1:1 for a period of 180 days (6 months), as one soft gel capsule once daily, to be taken 30 min after meals. Their respective MPOD values on Day 0, 60, 120 and 180 will be measured and analyzed. Subject’s daily intake of vitamin A and carotenoid, if any, will be captured in patient diaries. At the end of 3 and 6 months of treatment, interim analysis will be done in addition to complete data analysis towards end of the study (after 15 day follow-up).
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
- 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 density measurement
时间窗: Day 0, 60,120 and 180
次要结局
- Macular pigment ocular density(Day 0, 60, 120 and 180)