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CTRI Number  CTRI/2024/09/074298 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Lutein and Zeaxanthin Clinical trial on Eye health 
Scientific Title of Study   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.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/LZ/MPOD1/2024 Version: 1.0 Dated: 12th March 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant Research Services Pvt.Ltd 
Address  Radiant Research Services Private Limited # 99/A, 8 Main, III Phase, Peenya Industrial Area, Bangalore, Karnataka - 560058, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sravani T 
Designation  Manager -Technical 
Affiliation  Botanic Healthcare Pvt Ltd 
Address  TSIIC Industrial Development Area,Nacharan Village, Uppal Mandal, Hyderabad, Telangana - 500076,India

Hyderabad
TELANGANA
500076
India 
Phone  7995688815  
Fax    
Email  research1@botanichealthcare.net  
 
Details of Contact Person
Public Query
 
Name  Sravani T 
Designation  Manager -Technical 
Affiliation  Botanic Healthcare Pvt Ltd 
Address  TSIIC Industrial Development Area,Nacharan Village, Uppal Mandal, Hyderabad, Telangana - 500076,India

Hyderabad
TELANGANA
500076
India 
Phone  7995688815  
Fax    
Email  research1@botanichealthcare.net  
 
Source of Monetary or Material Support  
Botanic Healthcare Pvt Ltd TSIIC Industrial Development Area, Nacharam (V), Uppal (M), Hyderabad, Telangana – 500076, India  
 
Primary Sponsor  
Name  Botanic Healthcare Pvt Ltd  
Address  Botanic Healthcare Pvt Ltd TSIIC Industrial Development Area, Nacharam (V), Uppal (M), Hyderabad, Telangana – 500076, India  
Type of Sponsor  Other [Herbal Ingredients Manufactures] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rekha K R  The Oxford Medical College ,Hospital & Research Centre   Hosur Road Yadavanahalli,Ground floor Room no: 3 department of ophthalmology Attibele hobli,Anekal Taluk Bengaluru-562107 Bangalore – 562107.
Bangalore
KARNATAKA 
9481184438

rekhakrathnaiah@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics committe The Oxford Medical College, Hospital and Research centre  Approved 
Institutional Ethics committe The Oxford Medical College, Hospital and Research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Eye health on MPOD level along with Glare disability and Photo stress  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lutein-zeaxanthin  Dose: 500mg (Each capsule contains 20mg of lutein Zeaxanthin Dosage form:1 capsule per day, after breakfast Capsules Duration:90 days  
Comparator Agent  Placebo  Dose:500mg (Each capsule contain 0mg of lutein Zeaxanthin Dosage form:1 capsule per day, after breakfast Capsules Duration : 90days 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
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
 
Day 0, Day-45 and Day-90 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome:
1.To assess the safety of the product through Safety assessments like, hematology, and biochemistry (LFT and RFT)
 
Day 0 and Day-90 
 
Target Sample Size
Modification(s)  
Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   07/10/2024 
Date of Study Completion (India) 03/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Lutein Zeaxanthin 20:4 sourced from marigold scientifically known as Tagetes erecta which is the most abundant natural source of Lutein and Zeaxanthin. The flowers of the plant are used in the extraction of Lutein & Zeaxanthin using a unique extraction technique with Hexane as the solvent. It is uniformly dispersed in sunflower oil to create homogenized mixture. The product is brick red free flowing viscous paste with characteristic odour with lutein not less than 20% and Zeaxanthin not less than 4%. The product is narrow particle size distribution, which is largely responsible for its efficacy. These macular pigments protect eyes from oxidative processes when exposed to light acting as filters in that they improve vision by increasing both the Glare of objects and their background. Lutein and Zeaxanthin reduce the lipid peroxidation which leads to damage of biological membranes, resulting in ocular tissue damage and macular degeneration.



Macular pigments promote vision in a number of different ways. Blue light filtration lessens chromatic aberration, which can improve visual acuity. The supplementation is observed to elevate the levels of anti-oxidant enzymes significantly by their strong anti-oxidant effect, may reduce the oxidative damage and minimize oxidative stress. This prevents damage to the photoreceptors and retinal pigment epithelial cells. The mechanisms responsible for the action of Lutein and Zeaxanthin by actively quenching singlet oxygen and associated free radicals in the retina, they can further reduce oxidation by filtering blue light to prevent the development of reactive oxygen species, particularly singlet oxygen, in the retina. Also includes prevention of phototoxic damage by absorbing solar radiation, reduction of oxidative stress by scavenging ROS, and antioxidant, antiangiogenic, anti-inflammatory properties and naturally either help prevent or reduce the risk of progression of eye diseases like age related macular degeneration and cataracts.

 
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