Comparison of Nisha-amalaki and Metformin in Overweight and Obese Patients with Type 2 Diabetes Mellitus (Madhumeha): A Randomised Controlled Trial

Abstract

Introduction: Type 2 Diabetes Mellitus (T2DM) is considered a metabolic syndrome marked by an increase in blood sugar level brought on by absolute or relative insulin deficiency, insulin resistance, or both. It was predicted that 171 million individuals would develop type 2 diabetes at the turn of the century; by 2030, this figure is expected to reach 360 million. Nisha-amalaki is a commonly used medication for Type 2 Diabetes Mellitus, and its ingredients are also routinely used worldwide. There are numerous studies on Nisha-amalaki showing its antidiabetic effect, but it has not been studied in overweight and obese Type 2 diabetic patients; hence, present study is planned. Aim: To compare the efficacy of Nisha-amalaki and Metformin in overweight and obese patients with Type 2 Diabetes Mellitus. Materials and Methods: The present was a parallel-group, single-blind, randomised, standard controlled trial conducted in the Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. The trial included a 60-day treatment period and a followup period every 15 days. The study comprised a total of 60 overweight and obese patients suffering from Madhumeha, randomly divided into two equal groups. Group N (experimental group) was treated with 6 gm Nisha-amalaki Churna two times a day before meals with lukewarm water, and Group M (control group) was treated with 1 gm Tablet Metformin administered twice a day before meals in equal divided doses for 60 days. Patients were assessed for objective parameters like Fasting Blood Sugar (FBS) level, Post Meal Blood Sugar (PMBS) level, and Body Mass Index (BMI) at the start and end of the study. Statistical analysis was done by assessing through paired and unpaired t-tests and compared with the help of Z-test. Results: Madhumeha is more prevalent in the 51-60 years age group as well as in males compared to females. The mean FBS level before treatment was 151.98 mg/dL and 143.08 mg/ dL in Group M and Group N, respectively, which significantly reduced to 138.56 mg/dL and 129.39 mg/dL after treatment. The mean PMBS level before treatment was 232.45 mg/dL and 223.56 mg/dL in Group M and Group N, respectively, which reduced to 230.35 mg/dL and 209.26 mg/dL after treatment. The mean BMI before treatment was 26.49 mg/dL and 26.06 mg/dL in Group M and Group N, respectively, which reduced to 26.23 mg/dL and 25.86 mg/dL after treatment. Both the groups (standard as well as the trial group) are equally effective in reducing FBS level. During the follow-up visits, no adverse effects or side effects were observed in any patient. Conclusion: Both Nisha-amalaki Churna and Tablet Metformin are equally effective in reducing FBS level. Nisha-amalaki has a better effect compared to Metformin in reducing PMBS level. Metformin has a better effect compared to Nisha-amalaki in reducing BMI. So, it can be concluded that Nisha-amalaki Churna is as effective as Tablet Metformin in the management of overweight and obese patients suffering from Type 2 Diabetes Mellitus.