Clinical trial on eye health in healthy elderly volunteers.

A Prospective, Double Blind, Randomized, Placebo Controlled Interventional Study, to evaluate Safety and Efficacy of Centella Asiatica Extract tablets in Improving MPOD Levels in Elderly Volunteers.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019392

Enrollment

Registered

2019-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: CENTELLA ASIATICA 900 mg EXTRACT TABLETS: Dose: 900 mg Dosage: one tablet per day Route: orally Control Intervention1: Placebo containing Maltodextrin: Dose: 900 mg Tablet Dosage: one

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 optical density measurementTimepoint: Day 0,Day 60, Day 120 and Day 180	—

Secondary

Measure	Time frame
Safety parameters like Vitals,Liver function tests, Haematology and 4. Renal Function TestsTimepoint: Day 0 and Day 120	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt. Ltd

ashok@radiantresearch.in09880999297

Outcome results