None listed
Conditions
Interventions
Intervention1: Herbal Extract: Capsules given twice daily for 90 days
Control Intervention1: NA: There is no comparator agent in the study
Sponsors
ITC Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the efficacy of Herbal Extract for modulating the immune health in healthy adult volunteers Timepoint: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the safety of Herbal Extract in healthy adult volunteersTimepoint: NA | — |
Countries
India
Contacts
Public ContactT Vijay Bhaskar
Medical Monitor to provide clarifications for all scientific query
Outcome results
None listed