Preprint / Version 1

Preliminary clinical assessment and non- toxicity evaluation of an ayurvedic formulation BGR-34 in NIDDM

Authors

  • BP Gupta aAggarwal Dharmarth Hospital, New Delhi, India
  • I Sharma bResearch and Development, Aimil Pharmaceuticals (India) Ltd, New Delhi, India
  • N Kohli cAimil Healthcare and Research Centre, New Delhi, India
  • S Sharma bResearch and Development, Aimil Pharmaceuticals (India) Ltd, New Delhi, India
  • A Rathi bResearch and Development, Aimil Pharmaceuticals (India) Ltd, New Delhi, India
  • AK Sharma bResearch and Development, Aimil Pharmaceuticals (India) Ltd, New Delhi, India

Keywords:

BGR-34, Berberis aristata, NIDDM, Indian system medicine, Type 2 diabetes

Abstract

In view of the overall health impact of NIDDM, inventers understand the necessity of improving glycemic control in adults with type 2 diabetes. BGR-34 provides an effective treatment option for adults with type 2 diabetes who have been inadequately controlled on lifestyle with or without other oral hypoglycemic agents (OHGAs) such as metformin, sulfonylurea, or a glitazones. BGR-34 is an appropriate option to consider for addition to a managed care drug formulary. Treatment with BGR-34 produced clinically relevant and statistically significant reductions in all three key measures of glucose control studied —FPG, PPBG and HbA1c— when compared with placebo. BGR-34, showed the promising result with respect to glycemic parameters in NIDDM patient with a significant reduction in fasting blood sugar by 34.3%, postprandial blood sugar 35.5% & glycosylated haemoglobin by 20.31% as compared to placebo group showing a reduction by 13.2%, 10.9% & 10.87% respectively. The trial has also been registered to CTRI, India. This study has been registered in the clinical trial registry-India. Keywords: BGR-34, Berberis aristata, NIDDM, Indian system medicine, Type 2 diabetes Abbreviations: NIDDM, noninsulin-dependent diabetes mellitus; CSIR, council of scientific & industrial research, india; CTRI, clinical trial registry-India; OHGAs, other oral hypoglycemic agents; FPG, fasting plasma glucose; PPBG, post-prandial blood glucose; HbA1c, glycosylated haemoglobin; OECD, organization for economic co-operation and development; CPCSEA, committee for the purpose of conduct and supervisions of experiments on rats; TLC, TOTAL leukocyte count; DLC, differential leukocyte count; Hb, haemoglobin; SGPT, serum glutamate pyruvate transaminase; SGOT, serum glutamate oxaloacetate transaminase; ALP, alkaline phosphatase; BBN, total bilirubin; HDL, high-density lipoproteins; OPD, out Patient Department

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