Assessment of KaraShieldTM properties in supporting the immune health of healthy subjects: a randomized, parallel, double-blind, placebo-controlled clinical study

Abstract

Background: This study aims to investigate whether a novel herbal extract blend, KaraShieldTM could be used to help build a healthy immune system that could reduce the number of incidences or severity of common upper respiratory tract infections (URTIs). Methods: A randomized, parallel, double-blind, placebo-controlled clinical study of 60 days was done on 120 healthy subjects allocated to a treatment arm (500 mg/day, KaraShieldTM) or placebo arm (500 mg/day). Results: A 500 mg daily dosage of KaraShieldTM significantly improved the subjects' immune health as measured by parameters such as the frequency and severity of upper respiratory tract conditions, the serum IgG level, mean ISQ raw score, WURSS scale score, CRP level in the serum and WHOQOL-BREF score at the end of the study period of sixty days from the baseline compared to that of the placebo. The investigated product was found to be safe and well tolerated by the subjects. Conclusions: KaraShieldTM may represent a promising safe and effective formulation for building a healthy immune system that could then counteract URTIs.