A randomized comparative clinical trial to evaluate effect of Punarnavadi Kwath along with Triphala Guggulu with and without Chandanadi Seka in management of Pramehajanya Timira w.s.r. to diabetic macular edema.

ational Institute of Ayurveda0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1. Age between 35-70years.
•2. Central retinal thickness (CRT) at OCT > 300 microns to <600 microns.
•3. Diagnosis of Type 2 Diabetes Mellitus with HbA1C < 8.
•4. Clinically significant 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.

•1. Hypertensive patients with systolic BP >160 and diastolic BP >90 mm Hg.
•2. Diabetic patients with other cardiovascular problems like Coronary Artery Disease, Post Myocardial Infarction, Post Coronary Artery Bypass Graft cases.
•3. Anti-vascular endothelial growth factor treatment (Anti-VGEF) within 2 months, prior to enrollment.
•4. History of Pan Retinal Photocoagulation within 4 months prior to enrollment.
•5. History of ocular surgery within 4 months prior to enrollment.
•6. History of Retinal and ocular pathologies other than DME i.e. any active infection (e.g. Conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis), uncontrolled Glaucoma, mature cataract in either one or both eyes.
•7. Pregnant diabetic patients.
•8. History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4).
•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.

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