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CTRI Number  CTRI/2023/08/057023 [Registered on: 29/08/2023] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the effect of Lutein & Zeaxanthin on Visual improvement among the healthy subjects 
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 Chromatic Contrast 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja H V 
Designation  Assistant Professor 
Affiliation  Adichunchanagiri Hospital, Adichunchanagiri University, B.G.Nagara 
Address  Department of Ophthalmology

Mandya
KARNATAKA
571448
India 
Phone  9481528710  
Fax    
Email  poojahv1410@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Venkataraman 
Designation  Professor and Head 
Affiliation  Department of Pharmacy Practice, Head Clinical Trials,Clinical Trial Centre  
Address  Department of Pharmacy Practice Room No:35 Adichunchanagiri Hospital and Research Centre B.G.Nagara Clinical Trial Centre Adichunchanagiri Hospital and Research Centre B.G.Nagara

Mandya
KARNATAKA
571448
India 
Phone  9980038331  
Fax    
Email  rajeshvenky_research@hotmail.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 Bangalore

Hassan
KARNATAKA
560105
India 
Phone  9342575028  
Fax    
Email  rndstarhiherbs@gmail.com  
 
Source of Monetary or Material Support  
Star Hi Herbs Pvt.Ltd No.50, 3rd Road, 1st Phase, KIADB, Ind Area, Jigani, Bangalore  
 
Primary Sponsor  
Name  Star Hi Herbs PvtLtd  
Address  No.50, 3rd Road, 1st Phase, KIADB, Ind Area, Jigani, Bangalore  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Rajesh Venkataraman  Adichunchanagiri Hospital  Department Ophthalmology Adichunchanagiri Hospital Adichunchanagiri University B.G.Nagara
Mandya
KARNATAKA 		 9980038331

rajeshvenky_research@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of AH & RC, Adichunchanagiri Hospital & Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lutein (20 mg) & Zeaxanthin (4 mg/day)   Identical, brown-colored, soft gelatin capsule containing Lutein (20 mg) & Zeaxanthin (4 mg/day) long with standard of care, 1 capsule for 6 months 
Intervention  Lutein(10 mg) & Zeaxanthin (2 mg/day)  Identical, brown-colored, soft gelatin capsule containing Lutein (10 mg) & Zeaxanthin (2 mg/day) long with standard of care, 1 capsule for 6 months 
Comparator Agent  safflower seed oil  Contrast food (Placebo) is made with 100% of safflower seed oil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects aged 20 to 65 years old
2. BMI: 20 to 30kg/m2
3. Corrected eyesight is higher than 20/60 during eyesight testing (corrected visual acuity)
4. The subjects who have MPOD level between 0.2to 0.4 and those without any severe eye diseases.
5. The subjects who doesn’t have any problem on eye accommodation
6. The subjects who has drusen corresponding to early AMD (category 2) of AREDS
7. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation.
8. No Known metabolic diseases or gastrointestina
disorders and no known cognitive decline
9. No anticipated changes in dieting habits (as relevant to xanthophyll intake).
10. No anticipated surgical procedures.
11. Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
12. The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
 
 
ExclusionCriteria 
Details  1. Subjects with the complete vision loss
2. Subjects who are allergic to the study drug
3. Subjects suffering from severe or uncontrolled systemic or metabolic diseases.
4. Pregnant, lactating woman, or planning to become prenant.
5. Subjects who are taking any other medicine which interact with the study drug during the treatment
6. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any other condition that in the opinion of the investigator does not justify the inclusion of the subject in the study.
7. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s judgment affect the subject’s participation in the study.
8. Subjects who have participated in any other clinical trial in the past 30 days from the study start.
9. Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
10. Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
11. Subjects with hyperlipidemia (>6.2 mmol/L)
12. Ophthalmic patients other than AMD, retinal surgery and retinal laser treatment
13. Subjects with macular atrophy
14. Those with signs of exudative changes, including subretinal retinal fluid, pigmented epithelial detachment or bleeding
15. Subjects with 6 diopter and above myopia factors
16. Subjects with a cloudy cataract or cornea
17. Subjects who are taking hyperlipidemia control agents, controlled diets and a hormone replacement
18. Current use of xanthophyll containing supplements
19. Use of xanthophyll containing supplements in the past 6 months
20. Participation in any other study during last 3 month.
21. Blood donation during the last 3 months.
22. Known hypersensitivity or allergy to xanthophylls.
23. Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
24. Suspected lack of compliance with any requirements of the study.
25. Any relevant abnormalities in the routine laboratory tests
26. Smokers
27. Alcoholics
28. The subjects who are already undergoing the medications such as Lutein, Zeaxanthin, Omega3
29. The subjects who are on Beta-carotene, Astaxanthin, Anthocyanin, multi-vitamins, treatment with Retinal which is the form of Vitamin A-aldehyde,
30. The subjects taking the products of Functional ingredients that may help to eye health such as Bilberry extract, Haematococcus extract, Zeaxanthin extract, Lutein compound
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in macular pigment optical density (MPOD)
2. Lutein & Zeaxanthin amount in the blood 		 1. Change in macular pigment optical density (MPOD) at Day 1, Day 90, 180.
2. Lutein & Zeaxanthin amount in the blood at Day 0, Day 90, Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in glare disability & discomfort
2. Change in speeding photo stress recovery
3. Change in extending visual range
4. To measure improvement in chromatic contrast 		 Baseline (Visit 1) to Day 90, 180 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
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)  Other (Terminated) 
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)  		 The clinical study has been terminated based on the sponsor decision. We also confirm that the principal investigator has neither screened nor enrolled any subjects for this study 
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