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CTRI Number  CTRI/2025/05/086293 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Eye Health Clinical study. 
Scientific Title of Study   A Double-Blind, Placebo-Controlled Trial on the Effects of Lutein and Zeaxanthin on Macular pigment optical density response, Photo stress Recovery, Glare Disability, and Contrast Sensitivity. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/SHH/LZ/MPOD/2025 Version : 1.0 Date: 03 Feb 2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd 
Address  Radiant Research Services Pvt Ltd. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr C T SADASHIVA 
Designation  AGM R&D 
Affiliation  Star Hi Herbs Pvt Ltd 
Address  Star Hi Herbs Pvt. Ltd Plot No. 50, 3rd Road, 1st Phase K. I. A. D. B. Industrial Area, Jigani Bengaluru - 560105, Karnataka, India

Bangalore
KARNATAKA
560105
India 
Phone  9342575028  
Fax    
Email  rndstarhiherbs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr C T SADASHIVA 
Designation  AGM R&D 
Affiliation  Star Hi Herbs Pvt Ltd 
Address  Star Hi Herbs Pvt. Ltd Plot No. 50, 3rd Road, 1st Phase K. I. A. D. B. Industrial Area, Jigani Bengaluru - 560105, Karnataka, India

Bangalore
KARNATAKA
560105
India 
Phone  9342575028  
Fax    
Email  rndstarhiherbs@gmail.com  
 
Source of Monetary or Material Support  
Star Hi Herbs Pvt. Ltd Plot No. 50, 3rd Road, 1st Phase K. I. A. D. B. Industrial Area, Jigani Bengaluru - 560105, Karnataka, India  
 
Primary Sponsor  
Name  Star Hi Herbs Pvt. Ltd  
Address  Plot No. 50, 3rd Road, 1st Phase K. I. A. D. B. Industrial Area, Jigani Bengaluru - 560105, Karnataka, India 
Type of Sponsor  Other [ [Nutraceutical supplement company]] 
 
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 Aaditi Anilkumar MBBS DOMS DNB FVRS  Narayana Nethralaya, Rajajinagar, Eye hospital  Department of Ophthalmology 121/C, Chord Rd, Near Iskon Temple, 1st R Block, Rajajinagar, Bangalore – 560 010, India.
Bangalore
KARNATAKA 
7356266725

draaditianilkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H359||Unspecified retinal disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lutein 10mg and Zeaxanthin 2 mg  Dose :200mg,Doasge form:Capusle, Duration 120days, 1 capsule per day, after breakfast 
Intervention  Lutein 20mg and Zeaxanthin 4 mg  Dose:200mg,Doasge form:Capusle, Duration 120days, 1 capsule per day, after breakfast. 
Comparator Agent  Placebo  Dose:200mg,Doasge form:Capusle, Duration 120days, 1 capsule per day, after breakfast. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects aged from 20 to 65 years old inclusive of 20 exclusive of 65
2. Subjects who have MPOD level between 0.2 to 0.4 and those without any severe eye diseases.
3. Corrected eyesight is higher than 20/60 during eyesight testing corrected visual acuity.
4. The subjects who have drusen corresponding to early AMD category 2 of AREDS.
5. Subjects with BMI from 20 to 35 kgm2 inclusive of 20 exclusive of 35
6. Subjects able to give written informed consent and willing and able to comply with the study requirements.
 
 
ExclusionCriteria 
Details  1. Subjects who are allergic to the study drug known hypersensitivity to xanthophylls
2. The subjects taking Lutein Zeaxanthin Omega 3 Betacarotene Astaxanthin Anthocyanin multi-vitamins treatment with Retinal which is the form of Vitamin A-aldehyde and the products of Functional ingredients that may help to eye health such as Bilberry extract Haematococcus extract Zeaxanthin extract Lutein compound within the past 3 months.
3. Subject with current use of xanthophyll or history of using xanthophyll containing supplements within the past 6 months
4. Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
5. Subjects with the complete vision loss ophthalmic patients other than AMD macular atrophy retinal surgery retinal laser treatment a cloudy cataract or cornea
6. Subjects with myopia if more than 6 diopters
7. Subjects with signs of exudative changes including subretinal retinal fluid, pigmented epithelial detachment or bleeding
8. Subjects with hyperlipidemia greater than 6.2 mmol per L
9. Subjects suffering from severe or uncontrolled systemic or metabolic diseases known metabolic diseases or gastrointestinal disorders
10. Subjects with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc within the last 6 months However those who are clinically stable may participate in the trial at the investigator discretion
11. Subjects who are taking hyperlipidemia control agents controlled diets and a hormone replacement
12. Any relevant abnormalities in the routine laboratory tests
13. Those with a psychologically significant medical history or current disease schizophrenia epilepsy anorexia bulimia etc or a history of alcohol or the other drug abuse
14. Subject who are pregnant lactating woman or planning to become pregnant.
15. Subjects who have participated in any other clinical trial in the past 1 month from the study start.
16. Subjects who are deemed inappropriate to participate in this study by investigator AREDS category 2 Early AMD characterized by a combination of multiple small drusen a few intermediate drusen 63 to 124 microns in diameter or retinal pigment epithelium RP abnormalities.
 
 
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. Change from baseline (Visit1) in macular pigment optical density (MPOD)
2.Lutein and Zeaxanthin amount in the plasma concentration 
Day 1, Day 60, Day 120. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome:
1. Change in glare disability and discomfort from baseline
(Visit1) to Day 60, 120.
2. Change in speeding photo stress recovery from baseline
(Visit1) to Day 60, 120
3. Change in extending visual Field test from baseline (Visit1) to Day 60, 120
4. To measure improvement in contrast Sensitivity from
baseline (Visit1) to Day 60, 120.  
Day 1, Day 60, Day 120. 
 
Target Sample Size   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)   29/05/2025 
Date of Study Completion (India) 12/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Lutein (L) and zeaxanthin (Z) are two of the widely available carotenoids present in the normal diet of the human and responsible for the bright colors of numerous fruits and vegetables. [1]. R-isomer of Zeaxanthin majorly present in the macula of the retina, though small amounts of S-zeaxanthin isomer are also evident [1, 2]. Humans are unable to synthesize lutein and zeaxanthin isomers; thus, these nutrients are obtained from natural dietary sources or from supplementation [1]. These products can’t be synthesized by the human body but need to be absorbed from the human diet [2]. The activity of these supplements and their serum concentration vary from person to person [1]. The daily supplementation with L+Z was observed to have many clinical benefits including its increase in serum levels and MPOD, improvements in contrast sensitivity and recovery from photo stress [2]. The available clinical evidence needs to be confirmed with the long-term supplementation and its long-term effects. The present study was designed to assess the efficacy and safety of Lutein and Zeaxanthin over four months supplementation. 

Macular pigments promote vision in a number of different ways. Blue light filtration lessens chromatic aberration, which can improve contrast sensitivity and visual field test 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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