| 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
|
|
|
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
|
|
|
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. |