Herb-drug Interaction: Effect of Poly-Herbal Formulation on Glibenclamide Therapy in Patients with Type-2 Diabetes Mellitus
Background: The influence of poly-herbal formulation (Mehagni) on allopathic drug like glibenclamide mainly on plasma glucose level, lipid level and pharmacokinetic parameters in patients with type-2 diabetes mellitus. Methods and Result: Open-label, randomized clinical study was carried out for 90 days. Around 75 patients were screened out, based on their medication subjects were divided into group A&B 39 patients were in glibenclamide-2.5 mg (Daonil®) therapy and 36 patients were in poly-herbal formulation (Mehagni-500 mg, 2 tab/thrice a day) from past 6 months. Again 39 patients of glibenclamide therapy subdivided into group A1&A2. Group A1 (20) patients reviving glibenclamide-2.5 mg and group A2 (20) for combined study (GLB-1.5 mg+Mehagni 2 tab/twice a day). Initial day the study, analyze baseline demographic and clinical characteristics and that data was compared with end of the study report, in group A2 the high density lipoproteins (HDL) significantly increased as compared to group A1, the level of low-density lipoprotein (LDL) was significantly reduced. Bio-analytical method was developed to determine the concentrations of glibenclamide in plasma and pharmacokinetic interaction of Poly-herbal formulations on GLB therapy in type-2 diabetes mellitus patients, by using a Reverse Phase Ultra-Fast Liquid Chromatography– Photo Diode Array detector (RP-UFLC). Pharmacokinetic parameters of glibenclamide in the co-administration poly-herbal formulation such as area under the curve (AUC) and mean residence time (MRT) were increased while clearance (CL) was decreased. Conclusion: The co-administration of poly-herbal formulation (500 mg tablet twice a day) with glibenclamide may have beneficial effect to the patients in better glycemic control, lipid-lowering effect and bioavailability.