To assess the Safety and Effectiveness of Supplementation of Lutein Formulations on Improving Macular Pigment Optical Density
- Registration Number
- CTRI/2023/11/060356
- Lead Sponsor
- India Glycols Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
8.Smokers
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method