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首页> 外文期刊>Contemporary Clinical Trials Communications >Clinical evaluation of Emblica Officinalis Gatertn (Amla) in healthy human subjects: Health benefits and safety results from a randomized, double-blind, crossover placebo-controlled study
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Clinical evaluation of Emblica Officinalis Gatertn (Amla) in healthy human subjects: Health benefits and safety results from a randomized, double-blind, crossover placebo-controlled study

机译:Emblica Officinalis Gatertn(Amla)在健康人体主题中的临床评价:随机,双盲,交叉安慰剂对照研究的健康益处和安全结果

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摘要

The preventive efficacies and safety of Emblica Officinalis Gatertn (Amla), a most important and extensively studied plant in the traditional Indian Ayurvedic system of medicine, are presented. Eligible healthy adult subjects (n?=?15) were randomized to receive either amla or placebo (500?mg per day) during an 18-week study. The efficacy parameters evaluated were the vascular function, blood hematology, oxidative and inflammatory biomarkers, glucose and lipid profiles, urinalysis, and liver hepatotoxicity. The amla intake showed significant improvements in the primary efficacy parameter of blood fluidity. There were also improvements in the secondary endpoints including lowering of von Willebrand factor (vWF), reduced 8-hydroxy-2′-deoxyguanosine (8-OHdG) as well as thrombin (TM) biomarkers of oxidative stress along with a significant improvement in HDL-cholesterol and lowering the LDL-cholesterol levels. No substantial changes were observed in liver hepatotoxicity, urinalysis, and hematology after consumption of amla compared to baseline or placebo. In addition, no adverse events, changes safety parameters or tolerance issues were observed after consumption of amla. In conclusion, amla supplementation showed acceptable palatability, improved endothelial functions and reduced oxidative stress.
机译:提出了卓越的印度阿育吠陀医学系统中奥布莱克officinalis Gatertn(Amla)的预防性效率和安全性。符合条件的健康成人受试者(N?=?15)被随机化以在18周的研究期间接受AMLA或安慰剂(每天500毫克)。评估的疗效参数是血管功能,血液血液学,氧化和炎症生物标志物,葡萄糖和脂质谱,尿液分析和肝脏肝毒性。 AMLA摄入量显示出血液流动性的主要疗效参数的显着改善。次要终点还有所改善,包括降低von Willebrand因子(VWF),减少了8-羟基-2'-脱氧核苷酸(8-OHDG)以及氧化应激的凝血酶​​(TM)生物标志物以及HDL的显着改善-Choleterol并降低LDL-胆固醇水平。与基线或安慰剂相比,在AMLA消耗后,在肝肝毒性,尿液分析和血液学中没有观察到大量变化。此外,没有不良事件,在消耗AMLA后观察到安全参数或耐受性问题。总之,AMLA补充显示可接受的适口性,改善内皮功能和降低的氧化应激。

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