CTRI/2023/11/060356尚未招募3 期
A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety & Efficacy of Supplementation of Lutein Formulations on Improving Macular Pigment Optical Density in Healthy Adults - Nil
India Glycols Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Volunteers of either sex, between 18 to 50 (both inclusive) years of age.
- •2.Macular Pigment Optical Density (MPOD) 0.20-0.35 by flicker photometry both inclusive.
- •3.Volunteers with no clinically significant ocular pathological condition but having problems with accommodation can be included.
- •4.20/20 or corrected vision.
- •5.Able to give informed consent.
- •6.Willing to come for regular follow –up visits
排除标准
- •1.Macular Pigment Optical Density (MPOD) < 0.20 and >0.35.
- •2.History of age-related macular degeneration.
- •3.The presence of color blindness.
- •4.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations, AMD etc...
- •5.Individuals with only one functional eye.
- •6.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
- •7.History of epileptic seizures.
- •9.Individuals with a history of alcohol consumption in past 30 days and those unwilling and unable to commit to abstain from alcohol consumption during the study period.
- •10.Pregnant women & women who are planning for pregnancy during the study.
- •11.Individual who diagnosed with low macular pigment density within last three months and/or received any treatment for low macular pigment density.
- •12.Illiterate individuals.
- •13.Known history of hypersensitivity to herbal extracts or dietary supplements.
- •14.On-going treatment with herbals or allopathic ocular drugs.
- •15.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding six months or is currently ongoing.
- •16.Individual with any carotenoid trial participation history within the last one year.
- •17.Any condition that is in the opinion of the investigator does not justify the patient’s inclusion for the study.
- •18.Only the subjects whose screening data are within the inclusion and exclusion criteria defined, will be enrolled into the study. Those subjects who have screening values outside the normal limits may be enrolled only if the study doctor confirms in writing that these values are of no clinical significance and will have no impact on the outcome of the study.
研究者
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