Evaluation of comparative efficacy of Ayurvedic Formulation (Nimba-Amalakyadi Powder) as against Metformin in the management of Diabetes Mellitus Type II: A Clinical Trial Protocol (Preprint)

BACKGROUND In Ayurveda, Prameha (Diabetes mellitus) is considered Ashtamahagada Vyadhi (One among eight diseases difficult to treat) as difficult to cure. Tridosha (three bio-humor in Ayurveda) with certain metabolic factors are involved in its pathogenesis. Frequent urination is a common symptom of this disease. It can be correlated with Diabetes Mellitus Type II in conventional science due to the resemblance in cardinal features. OBJECTIVE The study’s objectives are to assess and compare the efficacy of Ayurvedic Formulation i.e. Nimba Amalakyadi formulation in powder form as against tab Metformin in the management of Diabetes Mellitus Type II. METHODS A total of 36 individuals with type II diabetes will be recruited and split into two equal groups at random. In Group A (Control), tab metformin (500mg) will be prescribed daily once before lunch with plain water for consecutive 45 days. In Group B (Interventional group), Nimba-Amalakyadi formulation will be prescribed 5 grams twice daily with an empty stomach i.e. 7 a.m.-5 p.m.) with lukewarm water for consecutive 45 days. Follow-up will be taken on days 45 and 90 to study the sustained effect of the drug. RESULTS Changes in the objective parameters, i.e., reductions in Blood Sugar Level (Fasting and postprandial) and Hb A 1 c values of patients will be observed and recorded CONCLUSIONS A conclusion will be drawn according to clinical findings obtained at baseline and follow-up visits with biochemical reports of the patients. The trial will prove the comparative efficacy of Nimba Amalakyadi formulation as against tablet Metformin in the management of Diabetes Mellitus Type II. CLINICALTRIAL CTRI/2021/08/036034