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临床试验/EUCTR2007-002168-84-DE
EUCTR2007-002168-84-DE进行中(未招募)不适用

Wirksamkeit und Verträglichkeit von Kneipp Arnika Salbe S bei stumpfen Sportverletzungen im Vergleich zu Ibutop Creme (Efficacy and Safety of Kneipp Arnika Salbe S for blunt impact sport injuries compared to Ibutop Creme) - Arnika Salbe S bei Sportverletzungen

Kneipp-Werke0 个研究点开始时间: 2007年8月10日最近更新:
适应症
相关药物

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

  • blunt impact injury (not older than 1 hour),
  • Age > 18 years,
  • Force-induced pain reaction (meassured in N) on injured side must be above 150% of pain reaction on contralateral uninjured site,
  • Informed consent acc. to § 40 AMG (German Drug Law)
  • 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) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Severe injury with e.g. massive swelling, rupture of ligament or fracture of the bone,
  • Open wound;
  • Any local or systemic drug treatment of the acute injury prior to enrolement,
  • Systemic treatment with NSAIDs, anagesics or steroids 2 days prior to enrolement and during the study,
  • Allergy or Hypersensitivity to any compenents of IMPs
  • Pregnancy and/or Nursing
  • Concurrent participation in another clinical trial
  • Drug or alcohol abuse

研究者

发起方
Kneipp-Werke

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