Comparative safety and study of Shadguna Makaradhwaja prepared from thin foils of gold and residue with Guduchi Ghana (aqueous extract of Tinospora cordifolia Miers.) in management of Madhumeha (type 2 diabetes): A double-blind, randomized, clinical trial

Abstract

Background: Diabetes turns out to be an intense worldwide public health problem. Makaradhwaja is in practice for the treatment of Madhumeha (diabetes mellitus) due to its Pramehaghna (antidiabetic) and Rasayana (immunomodulatory and rejuvenating) properties with the number of preclinical and clinical trials in diabetes. The present study was carried out to compare the efficacy of Shadguna Makaradhwaja prepared from (Varkha) thin foils of gold (SM-V) and Shadguna Makaradhwaja prepared from Apakwa Talastha Swarna Bhasma (residue of gold remained at the bottom of glass bottle during Kupipakwa) (SM-R) with Guduchi Ghana (GG) (aqueous extract of Tinospora cordifolia Miers) in type 2 diabetes. Materials and methods: In this prospective, randomized, double-blind clinical trial, 82 patients of type 2 diabetes were treated with SM-V with GG (250 mg) and SM-R with GG (250 mg) twice daily before food with honey for 28 days. The assessment of changes observed in hemogram, blood glucose, lipid profile, hepatic, renal profile, and clinical symptoms was carried out. Results: After 28 days of medication, fasting blood glucose level decreased significantly in SM-R, whereas postprandial blood glucose level significantly decreased in SM-V treated group. A significant improvement in subjective parameters and reduction in blood and urine sugar was noted with baseline. Hemogram and hepatic and renal function profiles (safety parameters) in both groups were not significantly different from the baseline. No adverse events were reported during the study period. Conclusion: SM-V, along with GG, is more effective in comparison with SM-R, thereby improving the quality of life of patients along with significant glycemic control and free from any untoward effect. Makaradhwaja can be used as an effective drug for diabetes.