<b>Evaluation of comparative efficacy of ayurveda formulation (</b><b><i>Nimba-Amalakyadi </i></b><b>Powder</b><b><i>) </i></b><b>as against Metformin in the management of diabetes mellitus type II: A clinical trial protocol</b>

<b>Background: </b>In Ayurveda, <i>Prameha </i>(Diabetes mellitus) is considered <i>Ashtamahagada Vyadhi (One among eight diseases difficult to treat) </i>as difficult to cure. <i>Tridosha</i> (three bio-humors in Ayurveda), with certain metabolic factors, is involved in its pathogenesis<i>.</i> Frequent urination is a common symptom of this disease. It can be correlated with type II diabetes mellitus in conventional science<i> </i>because of the resemblance in cardinal features.<i> </i><b>Objectives: </b>The objectives of this study were to assess and compare the efficacy of Ayurveda Formulation, that is, <i>Nimba Amalakyadi </i>formulation<i> </i>in powder form, against tab metformin in the management of type II diabetes mellitus.<b>Methods:</b>A total of 36 individuals with type II diabetes were recruited and randomly divided into two equal groups.In Group A (Control), metformin (500 mg) was prescribed once daily before lunch with plain water<b><i> </i></b>for 45 consecutive days. In Group B (interventional group), <i>Nimba-Amalakyadi </i>formulation<i> </i>will be prescribed 5 g twice daily with an empty stomach, that is, 7 a.m.-5 p.m.) with lukewarm water for 45 consecutive days. Follow-up will be performed on days 45 and 90 to study the sustained effects of the drug. <b>Expected </b><b>Results: </b>Changes in objective parameters, that is, reductions in blood sugar levels (fasting and post-prandial) and Hb A 1 c values of patients, will be observed and recorded. <b>Conclusion: </b>A conclusion will be drawn based on the clinical findings obtained at the baseline and follow-up visits with biochemical reports of the patients. This trial will prove the comparative efficacy of <i>Nimba Amalakyadi </i>formulation against the tablet metformin in the management of type II diabetes mellitus<b><i>.</i></b><br>