<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>背景：在阿育吠陀（Ayurveda）传统医学体系中，Prameha（糖尿病，Diabetes mellitus）被列为Ashtamahagada Vyadhi（八种难治疾病之一），治疗难度极高。阿育吠陀理论中的Tridosha（三大生物体液）联合相关代谢因素参与了该病的发病机制。多尿是该疾病的常见临床症状，由于二者核心临床表现高度相似，Prameha可与现代医学中的2型糖尿病（type II diabetes mellitus）相对应。 目标：本研究旨在评估并对比粉末剂型Nimba Amalakyadi复方与二甲双胍（metformin）片在2型糖尿病管理中的临床疗效。 方法：本研究共招募36名2型糖尿病患者，采用随机分组法将其均分为两组。对照组（A组）予以二甲双胍（500mg），每日1次，于午餐前以温开水送服，连续给药45天。干预组（B组）予以Nimba-Amalakyadi复方，每次5g，每日2次，空腹服用（每日早7时至晚5时），以温开水送服，连续给药45天。分别于给药第45天及第90天进行随访，以评估药物的持续疗效。 预期结果：本研究将观察并记录患者的客观指标变化，包括空腹血糖、餐后血糖水平以及糖化血红蛋白（Hb A1c）值的降低情况。 结论：本研究将基于基线与随访阶段的临床检查结果及患者的生化检验报告得出最终结论，以验证Nimba Amalakyadi复方对比二甲双胍片在2型糖尿病管理中的相对疗效。