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临床试验/CTRI/2017/09/009893
CTRI/2017/09/009893已完成未知

A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Immunomodulatory Effects of Functional Food Product in Healthy Adult Subjects

ITC Limited0 个研究点目标入组 180 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
ITC Limited
入组人数
180

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

入选标准

  • Healthy subjects of either sex aged 18 to 60 years
  • No antibiotics use within 2 months prior to entering the study or during the study
  • Not been vaccinated with current seasons influenza vaccine
  • Subjects able to provide written informed consent
  • Agree to receive a flu vaccine
  • If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study

排除标准

  • Subjects with deteriorating health status at the time of enrolment; rapid weight loss, terminal disease, significant chronic disease (example chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)
  • Recent blood donation (within 3 months from the date of screening)
  • Immunodeficiency disease (example human immunodeficiency virus [HIV] infection)
  • History of allergy, lactose intolerance, prior serious reaction to influenza vaccine, medication or supplement use that influences the immune system
  • Pregnant or breast feeding women
  • Currently participating or having participated in another clinical trial during the last three months prior to the beginning of this study
  • Conditions in the opinion of the investigator make the patient unsuitable to participate in the study
  • Any contraindication to blood sampling

研究者

发起方
ITC Limited

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