Comparative study of Nishaamalaki and metformin in obese patients of type 2 diabetes mellitus (Madhumeha): A study protocol

Abstract

Background Poor synthesis of insulin by beta cells present in the pancreas combined with resistance of insulin in peripheral organs is referred to as type 2 diabetes mellitus. Insulin resistance leads to an increase in plasma fatty acids, which reduces transfer of glucose within the cells of muscles and increases breakage of lipids, resulting in an increase in hepatic glucose production. Nishamalaki (a formulation of turmeric and Indian gooseberry) is suggested in the therapy of all kinds of Madhumeha (diabetes mellitus) in Ayurveda classics. Turmeric and Indian gooseberry are the two main ingredients. Both are considered as effective medicines in the management of Madhumeha individually as well as in combined form. Aim To compare the efficacy of Nishaamalaki and metformin in obese patients of type2 diabetes mellitus. Methods The study will include 60 obese type 2 diabetes mellitus patients who were distributed into two distinct categories, each with 30 patients. Nishamalaki Churna 3gm two times a day before food with warm water for 60 days in Group N (Experimental Group) and 500 mg metformin tablets twice daily before meals for 60 days in Group M (Control Group). Every 15th day, an assessment was made (15th, 30th, 45th and 60th day). Results Objective outcomes will be assessed. Conclusion: From this study protocol, it can be depicted that the trial formulation of turmeric and Indian gooseberry (Nisha-amalaki) is as effective in obese patients suffering from type- 2 diabetes mellitus as compared to metformin tablets.