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临床试验/EUCTR2008-008376-14-IT
EUCTR2008-008376-14-IT进行中(未招募)不适用

A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO INVESTIGATE EFFICACY AND SAFETY OF COMBINED TREATMENT OF GUGGULU AND TRIPHALA FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND OVERWEIGHT IN SUBJECTS NOT SUITABLE FOR THERAPY WITH STATINS - TRIGU PROJECT

AZIENDA ASL BRESCIA0 个研究点开始时间: 2009年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Ø Males and females 35-65 years of age Ø Total serum cholesterol 200-300 mg/dl Ø BMI > 25 and < 35 Ø Global cardiovascular risk: < 20% of events expected in next 10 years Ø Willingness to participate in and comply with the study Ø Willingness to give informed consent Ø Willingness to prevent conception during the study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Ø Documented hypersensitivity to the study treatment or its excipients Ø History of ischaemic heart disease Ø History of diabetes mellitus Ø Global cardiovascular risk: >= 20% of events expected in next 10 years and/or statin treatment Ø Presence of a severe chronic disease Ø Chronic therapy with any drug Ø Pregnancy or breast feeding

研究者

发起方
AZIENDA ASL BRESCIA

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