Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: XanMax 2004 (Lutein/Zeaxanthin 10 mg in ratio of 5:1): Dose:300mg (Each capsule contains 10mg of Lutein/ Zeaxanthin (5:1)
Dosage form: soft gel capsule
Route of administration: Oral
Sponsors
Katra Phytochem (India) Private Limited
Daehan Chemtech CO LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers of any sex, aged 45 to 65 years. 2. Volunteers with a body mass index (BMI) between 20 and 33 kg/m². 3. Volunteers with macular pigment optical density (MPOD) levels between 0.2 and 0.4. 4. Volunteers with no clinically significant ocular pathological conditions (minor and clinically insignificant accommodation issues of the eyes may be included). 5. Willing and able to adhere to the dietary regimen outlined in the study protocol. 6. Willing to attend regular follow-up visits as specified in the study protocol. 7. Capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to herbal extracts, dietary supplements, or study related components. 2. Presence of clinically significant ocular pathologies, including but not limited to glaucoma, mature cataracts, or pan-retinal degenerations. 3. History or diagnosis of systemic diseases such as hypercholesterolemia, renal disorders, hepatic disorders, diabetes mellitus, or other debilitating conditions. 4. Current or recent treatment in the last three months with herbal or allopathic ocular medications. 5. Participation in any other clinical trial or receipt of an investigational drug within the last three months. 6. Any condition that, in the investigators judgment, would preclude safe participation in the study or compromise study results. 7. Pregnant or lactating women, women planning to conceive during the study period, or women less than six months postpartum. 8. Prior use of lutein, zeaxanthin, or other antioxidant replacement therapies within the six months preceding the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in MPOD levelsTimepoint: Day 0, Day 60 and Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessments (hematology, serum chemistry and urine analysis)Timepoint: Day 0 and Day 120 | — |
Countries
India
Contacts
Public ContactMs Priya M K
Katra Phytochem (India) Private Limited
Outcome results
None listed