A study to assess the effect of Lutein & Zeaxanthin on Visual improvement among thehealthy subjects
- Registration Number
- CTRI/2023/08/057023
- Lead Sponsor
- Star Hi Herbs PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method