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
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