Efficacy and safety of Naga Bhasma and Nisha-Amalaki Churna in the management of Madhumeha (type 2 diabetes) - A double-blind, randomized, controlled clinical trial

Abstract

Abstract Background: Increasing global incidence of diabetes is a serious issue and large number of researches are undergoing to find promising cure of this chronic disease. Many Ayurveda drugs have been evaluated for anti-diabetic properties; however, researches on metallic/mineral based drugs are very few. The present study aimed to assess the comparative efficacy and safety of Shashti Puta Naga Bhasma (SNB) - Trimshati Puta Naga Bhasma (TNB) with Nisha-Amalaki Churna (NAC), NAC and metformin in the management of type 2 diabetes. Materials and methods: In this prospective, randomized, double blind, active controlled study; 132 patients with type 2 diabetes were included and randomly divided into four groups. Patients were treated with NAC (125 mg) with placebo (roasted Sooji; course powder of wheat flour), SNB (62.5 mg) with NAC (125 mg), TNB (62.5 mg) with NAC (125 mg) twice daily before food with honey while patients in last group were continued with their ongoing Tablet Metformin 500 mg prescribed by physician as standard control without any other additional intervention for 90 days. The assessment of changes observed in blood glucose, glycosylated hemoglobin, lipid profile, hemogram, hepatic, renal profile, and clinical symptoms was carried out. Results: After 90 days of medication, fasting and postprandial blood glucose levels and clinical symptoms in three groups were significantly decreased when compared with baseline except NAC group. Hemogram and hepatic and renal profiles (safety parameters) in the four groups were not significantly different from the baseline. No adverse events were reported with the use of the studied medicine. Conclusion: SNB along with NAC possessed more symptomatic relief in comparison to TNB with NAC, NAC alone and Metformin thereby improving the quality of life of patients along with significant glycemic control and free from any significant side effects.