A Clinical Study to Evaluate the Efficacy of Herbal Extract on Immune Health in Healthy Adult Volunteers
- Registration Number
- CTRI/2014/12/005247
- Lead Sponsor
- ITC Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
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
1. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the efficacy of Herbal Extract for modulating the immune health in healthy adult volunteers <br/ ><br>Timepoint: NA
- Secondary Outcome Measures
Name Time Method The secondary objective is to evaluate the safety of Herbal Extract in healthy adult volunteersTimepoint: NA