Lutein and Zeaxanthin Clinical trial on Eye health

A Randomized, double-blind, placebo-controlled clinical study to evaluate the modulatory effect of Lutein and Zeaxanthin supplementation on Macular Pigment Optical Density (MPOD), Glare disability and photo stress in healthy subjects. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074298

Enrollment

120

Registered

2024-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lutein-zeaxanthin: Dose: 500mg (Each capsule contains 20mg of lutein Zeaxanthin Dosage form:1 capsule per day, after breakfast Capsules Duration:90 days Control Intervention1: Placebo:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Volunteers of either sex, between 45 to 65 years of age. 2.Volunteers with MPOD level between 0.2 – 0.4 3.Volunteers having no clinically significant ocular pathological condition, but clinically non-significant problem with accommodation of the eye can be included. 4.Able to abide the dietary regime mentioned in the protocol 5.Willing to come for regular follow –up visits. 6.Able to give written informed consent Willingness to Take part in Study and able to attend all Scheduled Visits.

Exclusion criteria

Exclusion criteria: 1.Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial. 2.Not willing to Sign the ICF or give the consent 3.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc. will be excluded. 4.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases. 5.On-going treatment with herbals or allopathic ocular drugs. 6.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. 7.Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study

Design outcomes

Primary

Measure	Time frame
Primary Outcome: 1.Changes in MPOD levels 2.Changes in glare disability 3.Changes in Lutein and Zeaxanthin plasma concentrations 4.Percentage Change in Photostress recovery time Timepoint: Day 0, Day-45 and Day-90	—

Secondary

Measure	Time frame
Secondary Outcome: 1.To assess the safety of the product through Safety assessments like, hematology, and biochemistry (LFT and RFT) Timepoint: Day 0 and Day-90	—

Countries

India

Contacts

Public ContactSravani T

Botanic Healthcare Pvt Ltd

research1@botanichealthcare.net7995688815

Outcome results