Eye health Clinical trial on elderly volunteers
- Registration Number
- CTRI/2023/07/055671
- Lead Sponsor
- FFF Bio Works LLP
- 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 45 to 65 years of age.
2.Volunteers with MPOD level between 0.2 â?? 0.4
3.Volunteers having no clinically significant ocular pathological
4.condition, but clinically non-significant problem with
5.accommodation of the eye can be included.
6.Able to ae. Willing to come for regular follow â??up visits.
7.Able to give written informed consent.
1.Known history of hypersensitivity to herbal extracts or dietary supplements.
2.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc. was excluded.
3.Volunteers having systemic diseases like hyper cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
4.On-going treatment with herbals or allopathic ocular drugs.
5.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
6.Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Changes of MPOD <br/ ><br>2.Changes of glare disability <br/ ><br>3.Changes of lutein & zeaxanthin plasma concentrations <br/ ><br>Timepoint: Day 0,Day 90 & Day 180
- Secondary Outcome Measures
Name Time Method 1.Routine haematology <br/ ><br>2.Routine biochemistry tests <br/ ><br>Timepoint: Day 0 & Day 180