RANDOMIZED DOUBLE BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF NRL/LP/201901 CAPSULES AS ADJUVANT THERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Dr. Omkar Kulkarni*, Dr. Anuj Agarwal, Priya Khare, Gayatri Ganu and Dr. Medha Kulkarni

ABSTRACT

Background: Diabetes is swiftly gaining the status of a potential epidemic in India with more than 62 million diabetic individuals currently diagnosed with the disease. Herbal supplements target the different pathological events from different mechanistic approaches, to manage glucose homeostasis and to improve the quality of life of the patient. Aim: The aim of the study was to evaluate the efficacy and safety of NRL/LP/201901 capsules in type 2 diabetic patients. Materials and Methods: A randomized double blind, placebo controlled, comparative, interventional, multi-centric, prospective clinical Study was conducted. Subjects were advised to take a dose of 1 capsule orally after evening/night meal with water for 90 days. Following parameters were assessed during study- Fasting Plasma Glucose (FPG), 2-hr Post-Meal Glucose (PMG), Haemoglobin A1c (HbA1c), Fasting Insulin (FI) and 2-hr Post-Meal Insulin (PMI), b-cell functions by [HOMA]-b, insulin resistance (IR) by HOMA-IR, anthropometric measurements from baseline to end of visit. Results: 100 subjects completed the study. It was evident that NRL/LP/201901 capsules significantly reduced fasting and post meal glucose levels along with HbA1c, there was significant reduction in insulin resistance evident by HOMA IR score. The quality of life in patients was improved in NRL/LP/201901 capsule treated group. It also improved lipid profile and anthropometric parameters which may be helpful in preventing CVS complications in diabetes mellitus. C - reactive protein (CRP) levels were significantly reduced after treatment of test drug. Conclusion: Thus “NRL/LP/201901” capsule is safe and effective medicine as an adjuvant for the treatment of Diabetes type 2.

Keywords: Diabetes mellitus type2, HbA1c, Fasting insulin, herbal, CRP.