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CTRI Number  CTRI/2025/07/090887 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial to study the effect of Lutein and Zeaxanthin capsule on Eye Health in Adult Subjects. 
Scientific Title of Study   A Randomized, Double Blind, Two-Arm, Multi-centric, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Test Product on Macular Pigment Optical Density in Adult Subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B04664; Version: 01, Dated 21 Jan 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parth Joshi 
Designation  Overall Trial Coordinator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054.

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax    
Email  pjoshi@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Sethi 
Designation  Director-Consumer Research 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054.

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Dr Parth Joshi 
Designation  Overall Trial Coordinator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054.

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax    
Email  pjoshi@cliantha.com  
 
Source of Monetary or Material Support  
AK Biolink Co. Ltd., #612, A-dong, 5, Seongsuil-ro 8-gil, Seong dong-gu, Seoul, Republic of Korea 04793. 
 
Primary Sponsor  
Name  AK Biolink Co Ltd 
Address  #612, A-dong, 5, Seongsuil-ro 8-gil, Seong dong-gu, Seoul, Republic of Korea 04793. 
Type of Sponsor  Other [Distributor of Health functional food ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemaxi Desai  GCS Medical College, Hospital and Research Centre  Opp. DRM Office, Nr. Chamunda bridge, Naroda road, Ahmedabad – 380025, Gujarat, India.
Ahmadabad
GUJARAT 		 9898065645

drhemaxiben64@gmail.com 
Dr Arvind Jain  Lions Karnavati Shantaben Vishnubhai Patel Eye Hospital  Near Lml School, Gota Vadsar Road, Off S P Ring Road, Ognaj-380060
Ahmadabad
GUJARAT 		 7892737952

drarvindjain.research@gmail.com 
Dr Puja Shubham Negi  M & J Institute of Ophthalmology  Civil Hospital Ahmedabad Gujarat - 380016 India
Ahmadabad
GUJARAT 		 9925035087

pujabillore@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Anand Surgical Hospital IEC  Approved 
GCS Medical College, Hospital and Research Centre IEC  Approved 
M & J Institute of Ophthalmology IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lutein & Zeaxanthin complex  One capsule will be administered orally after breakfast for a duration of 180 days.  
Comparator Agent  Placebo   One capsule will be administered orally after breakfast for a duration of 180 days.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Subjects with MPOD levels between 0.2 – 0.4.
2) Subjects with best correction visual acuity better than 20 of 200 for each enrolled eye.
3) Female subjects of childbearing potential must have a negative serum pregnancy test performed at screening visit.
4) Subjects’ complete blood count parameters (RBC, WBC, Platelets, Differential Leukocyte count, Hb, PCV) to be within clinically acceptable range by Investigator. 
 
ExclusionCriteria 
Details  1) Pregnant or lactating women and women who are planning to get pregnant, or less than six months post-partum.
2) Subjects having other ocular pathologies e.g. glaucoma or age-related macular degeneration as assessed by the Investigator.
3) Subjects having systemic diseases like renal disorder, hepatic disorder, diabetes mellitus, hypercholesterolemia.
4) Subjects who are taking medicines or supplements (including supplements for Macular Degeneration) that affect the study.
5) Subjects with wet Exudative AMD (age related macular degeneration) in at least one eye.
6) Subjects with signs of exudative changes including subretinal fluid, pigment epithelial detachment, or hemorrhage in the retina.
7) Subjects with myopia of 6 diopters or more. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of products on Macular Pigment Optical Density (MPOD) using IDEVision MPS II  Day 00, Day 60, Day 120 and Day 180  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of products on Outer Nuclear Layer (ONL) Thickness, Retinal Pigment Epithelium (RPE) Layer Thickness and Central macular Thickness (CMT) and Central Foveal Thickness (CFT) using Optical Coherence Tomography (OCT)  Day 00, Day 60, Day 120 and Day 180  
To assess the effect of products on visual acuity using a standardized chart (Snellen chart).   Day 00, Day 60, Day 120 and Day 180  
To assess the effect of products on vision field measured using Perimetry.  Day 00, Day 60, Day 120 and Day 180  
Safety Assessments (ECG, Hematological and Biochemical Blood parameters, Urine parameters)  Screening and at the end of the study 
 
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   N/A 
Date of First Enrollment (India)   15/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This is a randomized, double blind, two-arm, multi-centric, placebo-controlled study to evaluate the effectiveness and safety of the test product on Macular Pigment Optical Density in adult subjects.

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

All eligible subjects will undergo ophthalmological assessment. Safety will be assessed throughout the study by monitoring adverse events.
 
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