Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
None listed
Sponsors
All India Institute Of Ayurveda , New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 35-70 years. 2. Central retinal thickness (CRT) at OCT will be in the range of 250 microns to 400 microns (Mild to Moderate). 3. Diagnosed patients of Type 2 Diabetes Mellitus on OHA with HbA1C 5.6-10. 4. Diabetic Macular Edema of less than 12 months duration. 5. Clear ocular media and adequate pupillary dilatation to allow fundus imaging. 6. Visual acuity 6/60 to 6/9. 7. Patients on other drug therapy will be included only after completion of the wash out period. 8. Patients on Ayurvedic or any other system of diabetic medicine will be taken after washout period.
Exclusion criteria
Exclusion criteria: 1. Mridukosth Patients 2. Hypertensive patients. 3. Proliferative Diabetic Retinopathy Patients. 4. Diabetic patients with other cardiovascular problems. 5. Those who took Anti-vascular endothelial growth factor treatment (Anti-VGEF) within 3 months, prior to enrolment. 6. History of Ocular surgery or LASER treatment within 3 months prior to enrolment. 7. History of Retinal and ocular pathologies other than DME i.e. any active infection (e.g. Conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis), Raised intra ocular pressure, mature cataract in either one or both eyes. 8. Pregnant patients. 9. Intraocular surgery (including cataract surgery) within 60 days preceding baseline. 10. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree. 11. Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve. 12. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. 13. Patients undergoing dialysis or having altered KFT Reports.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Central Retinal Thickness in DME.Timepoint: Day 0 (Baseline), Day 42 (End of Treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Visual Acuity. Changes in Quality of Life Measures Using National Eye Institute Visual Functioning Questionnaire 25. Symptom Perception like Metamorphopsia, Scotoma Contrast Sensitivity, Amsler s grid test findings after the intervention of trial drugs. Timepoint: Day 0 (Baseline), Day 42 (End of Treatment) | — |
Countries
India
Contacts
Public ContactDr Shubham Kumar
All India Institute of Ayurveda
Outcome results
None listed