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临床试验/EUCTR2009-016482-28-DE
EUCTR2009-016482-28-DE进行中(未招募)1 期

SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy - SUNIMUD

Charite Universitätsmedizin Berlin0 个研究点目标入组 40 人开始时间: 2010年3月15日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
40

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
Male

入选标准

  • Duchenne Muscular Dystrophy
  • Male patients > 4 years
  • ability to walk without help (a minimum of 75 meters)
  • maximum 2 cups of black tea, no consumption of grean tee, no consumption of greater amounts of grapefriut juice
  • Informed consent of parents
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 40
  • F.1.2 Adults (18-64 years) no
  • 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

  • serious other organic disease
  • known intolerance of Sunphenon
  • massiv and protracted exposure to sun
  • participation in other interventional clinical trials on pharmaceuticals or medical devices during the study or 3 months before
  • futher primary psychiatric/neurologic disorders
  • known allergy against Sunphenon EGCg or additives of the study medication or placebo capsules
  • longterm intake of liver toxic medication

研究者

发起方
Charite Universitätsmedizin Berlin

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