A Randomized, Double Blinded, Placebo Controlled, Clinical Study to Evaluate the Efficacy of Herbal Extract on Immune Health in Healthy Adult Volunteers

ITC Limited1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2014年11月6日最近更新: 2015年6月29日

试验速览

阶段: 不适用
状态: 已完成
发起方: ITC Limited
入组人数: 70
试验地点: 1
主要终点: The primary objective of this study is to evaluate the efficacy of Herbal Extract for modulating the immune health in healthy adult volunteers

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A randomized, double-blind, parallel-group, placebo-controlled study on healthy adult volunteers. The primary objective of this study is to evaluate the efficacy of herbal extract for modulating the immune health in healthy adult volunteers and secondary objective is to evaluate the safety of herbal extract in healthy adult volunteers. A total of 70 subjects will be enrolled in 3 groups. Repeated measure ANCOVA will be performed for the primary variables using baseline as covarites if data are measurable else t-test will be performed between the treatments.

研究设计

研究类型: Interventional
分配方式: Stratified block randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 55.00 Year(s)（—）
性别: All

入选标准

•1.Male or female healthy volunteers between 18 to 55 years of age at the time of screening visit 2.Subject willing to voluntarily sign the informed consent form 3.If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable since last 3 months prior to baseline and throughout the study.

排除标准

•Subjects with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhea, gastro-intestinal diseases, irritable bowel syndrome) 2.Autoimmune diseases, recent blood donation transfusion, immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection) 3.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 4.Subjects unwilling or unable to comply with the study procedures.

结局指标

主要结局

The primary objective of this study is to evaluate the efficacy of Herbal Extract for modulating the immune health in healthy adult volunteers

时间窗: NA

次要结局

The secondary objective is to evaluate the safety of Herbal Extract in healthy adult volunteers(NA)

研究者

发起方

ITC Limited

申办方类型

Other [fmcg]

研究点 (1)

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