| 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
|
|
|
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
|
|
|
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. |