A randomized double-blind clinical trial is conducted on 72 type 2 diabetic men and women (36 people in each group) for 3 months. Among diabetes patients who come to diabetes center, subjects who have 30-60 years old and receive regular type 2 diabetes drugs was chosen. Patients who receive insulin, Cardiovascular, renal, liver, thyroid disorders, patients who receive anti coagulant (aspirin, vitamin E, and other herbal) drugs and pregnant and lactation women were excluded after matching subjects for age, sex and duration of diabetes. Subjects divided into intervention and placebo group randomly. Intervention group receive 3 black seed capsules that contain 1000 mg black seed extract, and placebo group receive three 1000 mg sunflower oil capsules before each meals for 3 months.
In beginning and end of the 3 months, a blood sample was collected from subjects after 12-14 hours fasting and biochemical analyses were conducted that include: fasting blood sugar(FBS), Glycated hemoglobin(hba1c), total cholesterol(TC), High density lipoprotein(HDL), triglyceride(TG) and Low density lipoprotein(LDL) is calculated by friedwald equation. Anthropometric measurements, systolic and diastolic blood pressure, 24hr diet recall and physical activity also measures in beginning and end of the study.