Health Condition 1: H359- Unspecified retinal disorder
Conditions
Interventions
Intervention1: Lutein 10mg and Zeaxanthin 2 mg: Dose :200mg,Doasge form:Capusle, Duration 120days, 1 capsule per day, after breakfast
Intervention2: Lutein 20mg and Zeaxanthin 4 mg: Dose:200mg,Doasge
Sponsors
Star Hi Herbs Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: 1. Change from baseline (Visit1) in macular pigment optical density (MPOD) 2.Lutein and Zeaxanthin amount in the plasma concentrationTimepoint: Day 1, Day 60, Day 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 1, Day 60, Day 120. | — |
Countries
India
Contacts
Public ContactDr C T SADASHIVA
Star Hi Herbs Pvt Ltd
Outcome results
None listed