OPEN LABEL CLINICAL TRIAL TO STUDY ADVERSE EFFECTS AND TOLERANCE TO DRY POWDER OF THE AERIAL PART OF ANDROGRAPHIS PANICULATA IN PATIENTS TYPE 2 WITH DIABETES MELLITUS

Adverse effects and tolerance to dry powder of aerial part of Andrographis paniculata (Burm.f.) Nees were studied in 20 patients with type 2 diabetes mellitus for a period of 12 weeks. Patients were given powdered A. paniculata starting with 600 mg daily, gradually increasing to a maximum of 1.8 gm daily. Parameters monitored included body weight, blood pressure, liver function tests, renal function tests, cardiac enzymes, haemogram, serum electrolytes, fasting blood glucose, HbA1c, blood cholesterol, serum triglycerides and blood hormone levels (tri- iodotyronine, thyroxine, thyrotropin, insulin, fasting cortisol). None of the above mentioned parameters showed significant change during the study period except for a fall in HbA1c by 5.46%(p 0.01) and fasting S. insulin by 20.93%(p 0.003). In conclusion, A. paniculata powder did not induced significant adverse events based on parameters observed in our study but significantly lowered HbA1c and fasting serum insulin in patients with type 2 diabetes.