SAFETY AND EFFICACY OF MAHAGNIWATI IN THE MANAGEMENT OF NON PROLIFERATIVE DIABETIC RETINOPATHY (NPDR): AN OPEN LABELLED, RANDOMIZED, CONTROLLED CLINICAL TRIAL

Abstract

Background : Diabetic retinopathy is the most dreaded complication of ocular manifestation caused by diabetes. Newer conventional therapies report limited efficacy with considerable adverse effects. On contrary, experimental studies with herbal intervention have reported promising results. This study aims to evaluate the safety and efficacy of polyherbal formulation (coined as “Mahagniwati”) compared to standard oral treatment of antioxidants (Tab. Retinox®) in the management of patients with non-proliferative diabetic retinopathy. Methodology : An open labelled, randomized, controlled clinical trial was conducted (CTRI no. CTRI/2016/04/006797) on 66 patients divided in two groups (n=33 in each group) viz., Group A (Tab. Retinox® 1 OD), Group B (Tab. Mahagniwati, 500mg BD) daily for 6 months in addition to oral hypoglycaemic agents as advised by physician.As per SCI-027 Guidelines for diabetic retinopathy Royal College of Ophthalmology 2005,degree of severity of non-proliferative diabetic retinopathy was assessed.Assessments were conducted at an interval of six months compared with baseline in functional parameters viz., dazzling macula test, visual acuity, quality of life, intraocular pressure (IOP), and fundus photographs with monthly monitoring of plasma glucose. Wilcoxon-sign rank test & Mann Whitney U test were applied to evaluate micro-aneurysm, dot & blot haemorrhage, soft exudates, cottonwool patches for intra group and inter group analysis respectively and t test was applied for best corrected visual acuity. Results : Among 66 patients, maximum patients had soft exudates, dot and blot haemorrhages and micro aneurysm. Mahagniwati was safe and possessed statistically significant efficacy in mild to moderate non-proliferative diabetic retinopathy (NPDR) with hypoglycaemic and lipid lowering activity.