Health Condition 1: H353- Degeneration of macula and posterior pole Health Condition 2: null- Dry type age related macular disorder
Conditions
Interventions
Intervention1: MacumaxTM: One capsule b.i.d. (one capsule in the morning and one capsule in the night after food for 90 days).
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex, > 50 years of age. 2 Patients having signs and symptoms of AMD (Dry type). 3 Willing to come for regular follow up visits. 4 Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1 Known history of hypersensitivity to herbal extracts or dietary supplements. 2 Patients having other ocular pathologies like glaucoma, high myopia, mature cataract, pan retinal degenerations etc. were excluded. 3 Patients having systemic diseases like hyper cholesterolemia, renal disorder, liver disorder and other debilitating diseases. 4 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test. 5 On going treatment with herbal or allopathic ocular drugs. 6 History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently on going.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Improvement in subjective symptomsTimepoint: 1 Improvement in subjective symptoms(Screening, Visit 2, Visit 3 and Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Improvement in distant vision 2 Improvement in pin hole vision 3 Improvement in the fundus changes 4 Optical coherence tomography changes 5 Amslers grid aberration changes 6 Improvement in visual fieldTimepoint: 1 Improvement in distant vision (Screening, Visit 1, Visit 2, Visit 3 and Visit 4) 2 Improvement in pin hole vision (Screening, Visit 1, Visit 2, Visit 3 and Visit 4) 3 Improvement in the fundus changes(Screening and Final Visit) 4 Optical coherence tomography changes(Screening & Final Visit) 5 Amslers grid aberration changes (Screening, Visit 2, Visit 3 and Visit 4) 6 Improvement in visual field (Screening, Visit 2, Visit 3 and Visit 4) | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
ClinWorld Private Limited
Outcome results
None listed