None listed
Conditions
Interventions
Intervention1: IXAN® capsule containing Curcuminoids, Lutein and Zeaxanthin: Dose : 70 mg
Dosage form: Capsules
Frequency: Once daily after food
Duration: 180 Days
Control Intervention1: Placebo: Dos
Sponsors
FFF Bio Works LLP
Eligibility
Inclusion criteria
Inclusion criteria: 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 4. condition, but clinically non-significant problem with 5. accommodation of the eye can be included. 6. Able to ae. Willing to come for regular follow –up visits. 7. Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to herbal extracts or dietary supplements. 2. Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc. was excluded. 3. Volunteers having systemic diseases like hyper cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases. 4. On-going treatment with herbals or allopathic ocular drugs. 5. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. 6. Any condition that in the opinion of the investigator does not justify the subject"s inclusion for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes of MPOD 2.Changes of glare disability 3.Changes of lutein & zeaxanthin plasma concentrations Timepoint: Day 0,Day 90 & Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Routine haematology 2. Routine biochemistry tests Timepoint: Day 0 & Day 180 | — |
Countries
India
Contacts
Public ContactJayaram Bharathi
FFF Bio Works LLP
Outcome results
None listed