Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study
Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study
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DOI：
10.1016/j.ctim.2015.06.005
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发表时间：
2015-08-01
影响因子：
3.6
通讯作者：
Sawlani, Kamal Kumar
中科院分区：
文献类型：
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作者：
Awasthi, Harshika;Nath, Rajendra;Sawlani, Kamal Kumar
目的：本研究的目的是调查一个标准化的多草药配方的疗效，包括水提取物从六个草药，在2型diabetesmellites.Design患者：随机，积极的对照研究。将93例新诊断的2型糖尿病患者随机分为I组（接受复方草药胶囊500 mg/天，每周滴定至最大3 giclay）和组2（接受Metaldehyde 500 mg/天，每周向上滴定至最大2g/天）。主要终点是对血糖（空腹血糖和餐后血糖）和糖化血红蛋白（HbA 1c）较基线变化的影响。结果：治疗24周后，治疗组空腹血糖和餐后血糖分别下降25.52%和24.22%，二甲双胍组分别下降31.46%和24（估计治疗差异分别为-10.8; 95% CI -22.63至1.03和-0.36; -12.1至11.38）。PHF和二甲双胍的HbA 1c降低也相似（估计治疗差异0.01; 95% CI -0.51至0.53）。然而，PHF给药组（估计平均差异61.3; 95% CI 55.32 - 67.28）中平均总胆固醇水平的降低比二甲双胍给药组（估计平均差异41.12; 95% CI 34.92 - 47.32）更明显。治疗6个月后，两组间总胆固醇水平差异有统计学意义（估计治疗差异20.18; 95% CI 12.34 - 28.02）。结论：研究表明，每日摄入这种PHF可降低血糖水平，改善脂质稳态，同时维持其他血清生化水平正常，因此，它可能对2型糖尿病患者有用。(C)2015爱思唯尔有限公司版权所有。
Objectives: The purpose of this study was to investigate the efficacy of a standardized polyherbal formulation consists of aqueous extracts from six herbs, in patients with Type-2 diabetes mellitus.Design: Randomized, active control study.Interventions: 93 patients, newly diagnosed with Type-2 diabetes mellitus were randomly allocated to group I (received polyherbal capsules 500 mg/day, up titrated weekly to a maximum of 3 giclay) and group 2 (received Metformin 500 mg/day, up titrated weekly to a maximum of 2g/day).Main outcome measures: The primary endpoint was effect on the change from baseline in blood glucose (Fasting blood Glucose and Postprandial blood glucose), and glycosylated hemoglobin (HbA1c). The secondary outcome includes the effect on lipid levels, liver enzymes and renal function test.Results: After 24 weeks, mean laboratory measured fasting and post prandial blood glucose showed a decrease of 25.52% and 24.22% in polyherbal formulation (PHF) treated group, compared to 31.46% and 24% decrease in Metformin treated group (estimated treatment difference -10.8; 95% CI -22.63 to 1.03 and -0.36; -12.1 to 11.38, respectively). Reduction in HbA1c was also similar for PHF and Metformin (estimated treatment difference 0.01; 95% CI -0.51 to 0.53). However, the decrease in the mean total cholesterol level was more pronounced in PHF treated group (estimated mean difference 61.3; 95% Cl 55.32 to 67.28) than Metformin treated group (estimated mean difference 41.12; 95% Cl 34.92 to 47.32). Also, there was statistical significance between the treatment groups in total cholesterol level at the end of six months treatment (estimated treatment difference 20.18; 95% Cl 12.34 to 28.02).Conclusion: The study demonstrated that daily intake of this PHF decreased the glycemic level and improved lipid homeostasis, while maintaining the other serum biochemical levels to the normal, and therefore it may be useful for the patients with Type-2 diabetes. (C) 2015 Elsevier Ltd. All rights reserved.