A clinical study to evaluate the efficacy of Macumaxcapsules in adultmale or female patients suffering from dry type Age related macular disorder.
- Conditions
- Health Condition 1: H353- Degeneration of macula and posterior poleHealth Condition 2: null- Dry type age related macular disorder
- Registration Number
- CTRI/2016/02/006676
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Improvement in subjective symptomsTimepoint: 1 Improvement in subjective symptoms(Screening, Visit 2, Visit 3 and Visit 4)
- Secondary Outcome Measures
Name Time Method 1 Improvement in distant vision <br/ ><br>2 Improvement in pin hole vision <br/ ><br>3 Improvement in the fundus changes <br/ ><br>4 Optical coherence tomography changes <br/ ><br>5 Amslers grid aberration changes <br/ ><br>6 Improvement in visual fieldTimepoint: 1 Improvement in distant vision (Screening, Visit 1, Visit 2, Visit 3 and Visit 4) <br/ ><br>2 Improvement in pin hole vision (Screening, Visit 1, Visit 2, Visit 3 and Visit 4) <br/ ><br>3 Improvement in the fundus changes(Screening and Final Visit) <br/ ><br>4 Optical coherence tomography changes(Screening & Final Visit) <br/ ><br>5 Amslers grid aberration changes (Screening, Visit 2, Visit 3 and Visit 4) <br/ ><br>6 Improvement in visual field (Screening, Visit 2, Visit 3 and Visit 4)