Aim: Reviewing the safety rate and metabolic effects of administration of methanolic extract of Berberis artistata root (Local Barberry) in comparison with metformin tablets in type 2 diabetic patients
Design: Randomized clinical trial, double blinded, control by placebo, single center
Implementation method: Sixty diabetic clinic outpatients with Balance blocked Randomization are divided to two groups of 30 in each (with loss retention) that in the first group (Group A) patients take Berberis artistata root methanolic extract wich is made in capsule form and placebo of metformin tablet orally and they are controlled by diet and exercise. The second group (Group B), which is the control group, takes two 500-mg Metformin tablets twice in a day plus placebo of berberis aristata capsules and they are controlled by diet and exercise. Blood and urine samples, clinical examination and questionnaire in two studied groups are reviewed in time periods of 0, 15, 45 and 90 days of treatment.
Participants: diabetic clinic outpatients (Inclusion criteria: type 2 diabetics, age of 18-75 years, Exclusion criteria: patients with other chronic diseases, treatment by insulin)
Interventions: Administration of methanolic extract of Berberis artistata root and Metformin
Main outcome: Fasting blood sugar, 2-hours post breakfast blood sugar, Glycated hemoglobin
Other variables from complications viewpoint: Creatinine, Triglyceride, Cholesterol, High Density Lipoprotein, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase Bilirubin, Thromboplastin Time, Prothrombin Time, complete blood cell Count