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Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial

Amrut Salunke, Hema Kolpe, Amit Nakanekar.

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.

Key words: Non proliferative diabetic retinopathy (NPDR), Ayurveda formulation, Mahagniwati, Antioxidants


 
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Pubmed Style

Salunke A, Kolpe H, Nakanekar A. Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. AAM. 2021; 10(3): 220-230. doi:10.5455/AAM.55936


Web Style

Salunke A, Kolpe H, Nakanekar A. Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. http://www.aamjournal.in/?mno=55936 [Access: October 19, 2021]. doi:10.5455/AAM.55936


AMA (American Medical Association) Style

Salunke A, Kolpe H, Nakanekar A. Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. AAM. 2021; 10(3): 220-230. doi:10.5455/AAM.55936



Vancouver/ICMJE Style

Salunke A, Kolpe H, Nakanekar A. Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. AAM. (2021), [cited October 19, 2021]; 10(3): 220-230. doi:10.5455/AAM.55936



Harvard Style

Salunke, A., Kolpe, . H. & Nakanekar, . A. (2021) Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. AAM, 10 (3), 220-230. doi:10.5455/AAM.55936



Turabian Style

Salunke, Amrut, Hema Kolpe, and Amit Nakanekar. 2021. Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. Annals of Ayurvedic Medicine, 10 (3), 220-230. doi:10.5455/AAM.55936



Chicago Style

Salunke, Amrut, Hema Kolpe, and Amit Nakanekar. "Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial." Annals of Ayurvedic Medicine 10 (2021), 220-230. doi:10.5455/AAM.55936



MLA (The Modern Language Association) Style

Salunke, Amrut, Hema Kolpe, and Amit Nakanekar. "Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial." Annals of Ayurvedic Medicine 10.3 (2021), 220-230. Print. doi:10.5455/AAM.55936



APA (American Psychological Association) Style

Salunke, A., Kolpe, . H. & Nakanekar, . A. (2021) Safety and efficacy of Mahagniwati in the Management of non proliferative Diabetic Retinopathy (NPDR) : An open Labelled, Randomized, Controlled Clinical Trial. Annals of Ayurvedic Medicine, 10 (3), 220-230. doi:10.5455/AAM.55936








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