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
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
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