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临床试验/ISRCTN16094368
ISRCTN16094368已完成未知

Double-blind, randomized, placebo-controlled clinical study to evaluate efficacy and safety of Yestimun® in subjects with increased susceptibility to common cold

eiber GmbH (Germany)0 个研究点目标入组 224 人开始时间: 2012年8月3日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
224

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age: = 18 years (child-bearing females had to agree to use appropriate birth control methods)
  • 2. At least three common cold infections within the last six months
  • 3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply

排除标准

  • 1. Acute infection of the upper airways (e.g. acute bronchitis)
  • 2. Chronic upper airway disease (e.g. chronic bronchitis, tonsillitis or asthma)
  • 3. Chronic cough of any origin
  • 4. Chronic rhinitis (vasomotor or allergic rhinitis)
  • 5. Congenital or acquired immunodeficiency disease (e.g. HIV infection)
  • 6. Acute or chronic diarrhea
  • 7. Severe organ or systemic diseases
  • 8. Suspected swine flu or influenza
  • 9. Body temperature above 37.5°C
  • 10. Vaccination against influenza or swine flu within 21 days prior to study start
  • 11. Known hypersensitivity to ingredients of the investigational product
  • 12. Pregnancy and lactation
  • 13. Use of immunosuppressants
  • 14. Use of immunostimulants (e.g. Echinacea) within the last 14 days prior to study start
  • 15. Use of antibiotics within the last 14 days prior to study start
  • 16. Alcohol/drug abuse; drug addiction
  • 17. Simultaneous participation in another clinical trial or participation in a clinical trial within the last 4 weeks
  • 18. Regular use of other yeast preparations
  • 19. Incertainty regarding compliance

研究者

发起方
eiber GmbH (Germany)

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