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临床试验/NCT01286909
NCT01286909Unknown3 期

Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

Omicron Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
40
试验地点
1
主要终点
Increase in High-Density Lipoprotein (HDL)

研究概览

简要总结

A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and Women with Metabolic Syndrome
  • Elevated Triglycerides (> 150)
  • Low High-Density Lipoprotein (HDL) (< 35)
  • Willingness to take study nutritional supplement once a day for 3 months

排除标准

  • Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
  • Known milk, soy or whey allergy

结局指标

主要结局

Increase in High-Density Lipoprotein (HDL)

时间窗: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months

次要结局

  • changes of liver enzymes(Baseline and 3 months)

研究者

发起方
Omicron Pharmaceuticals
申办方类型
Industry

研究点 (1)

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