None listed
Conditions
Interventions
Intervention1: XanMax® 2002: Lutein and Trans-Zeaxanthin and sunflower oil
Dose - 20 mg
Frequency - one soft gel capsule once daily 30 minutes after meals
Duration - 6months
Route of Administration
Sponsors
Katra Phytochem India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: a.Volunteers of either sex, between 45 to 65 years of age. b.Volunteers with MPOD level between 0.2 â?? 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 â??up visits. f.Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 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 patientâ??s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular pigment density measurementTimepoint: Day 0, 60,120 and 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular pigment ocular densityTimepoint: Day 0, 60, 120 and 180 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Kathra Phytochem (India) Pvt Ltd
Outcome results
None listed