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临床试验/NCT00654459
NCT00654459已完成不适用

Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Federico II University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.

研究概览

简要总结

Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females aged between 18 and 70
  • Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl;
  • Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

排除标准

  • Proven intolerance to an Armolipid Plus compound
  • Pregnant women, and women planning to conceive
  • Patients in therapy with lipid lowering drugs within the previous 6 weeks
  • Triglycerides concentration > 500mg/dl were excluded.

结局指标

主要结局

The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.

时间窗: 6 weeks

次要结局

  • Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.(6 weeks)

研究者

发起方
Federico II University
申办方类型
Other

研究点 (1)

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