Abstract
Background: Diabetes mellitus (DM) is one of the oldest common metabolic disorders characterized by hyperglycemia, hyperlipidemia, negative nitrogen balance, and ketonemia. It is a one of the most important pathological conditions associated with dyslipidemia that affects the whole body system. Several types of DM exist and result by a complex interaction of genes and drugs, gestational diabetes, environmental factors such as stress and sedentary lifestyle choices. DM is the leading cause of end-stage renal disease, coronary artery disease, cerebrovascular disease, nontraumatic lower extremity amputations, and adult blindness.

Aims and Objectives: This study was conducted to evaluate the hypolipidemic effect of stem part of Berberis aristata in patients of Type 2 DM with dyslipidemia as add on therapy.

Materials and Methods: A prospective randomized open parallel group study was conducted in total 90 patients having high fasting blood sugar (FBS) and dyslipidemia of either sex in the age group of 30-60 years attending of outpatient/indoor Department of Medicine of Muzaffarnagar Medical College and Hospital, Muzaffarnagar, Uttar Pradesh, India. A total of 103 each Group 1 (N = 30) was taken as control while Group 2 (N = 30) and Group 3 (N = 30) was taken as study group who had received 1.5 and 3 g of B. aristata, respectively, as add on therapy along with their conventional antidiabetic and antihyperlipidemic (in certain number of patients) treatment. During the study, 13 patients (8 male and 5 female) did not complete the study and reason of premature withdrawal included protocol violation.

Results: In our study, there were a statistically a highly significant improvement and stabilization of glycemic control in test Groups 2 and 3 when compared with control group (P < 0.01). In Groups 2 and 3, reduction of FBS level from 1 month onward. The mean high density lipoprotein level improved significantly in the Group 2 (P < 0.01) and highly significantly in Group 3 (P < 0.001) as compared to control. The mean total cholesterol level decreased no significantly in the Group 2 (P > 0.05) and highly significant in Group 3 (P < 0.001) as compared to control. The mean triglyceride level decreased highly significantly in the Group 2 and Group 3 (P < 0.001) as compared to control. The mean low density lipoprotein level decreased highly significant in the Group 2 and Group 3 (P < 0.001) as compared to control.

Conclusion: It can be concluded that B. aristata as an add on therapy in Type 2 DM patients has a beneficial role with regard to the hyperglycemia and dyslipidemia very safe as no major side effects were observed affecting morbidity and mortality. Hence, B. aristata as an add on therapy could represent a good treatment option before initiating insulin and hypolipidemic therapy in diabetic patient with suboptional glycemic and lipideimic control to avoid unwanted adverse effects and can cut down cost of treatment.

Key words: Type 2 Diabetes Mellitus; Dyslipidemia Berberis aristata; Add on Therapy