Efficacy and safety of the syrup "KalobaTUSS®" as a treatment for cough in children: a randomized, double blind, placebo-controlled clinical trial.

<bold>Background: </bold>Acute cough in children often causes discomfort to children and parents, reducing their quality of life. Despite the extensive utilization of over-the-counter remedies for cough, the efficacy of most of these treatments in children has not been confirmed.<bold>Methods: </bold>We conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS®, a paediatric cough syrup based on acacia honey and on Malva sylvestris extract, Inula helenium extract, Plantago major extract, and Helichrysum stoechas extract by using a validated 6 points Likert scale.<bold>Results: </bold>Children were orally treated with KalobaTUSS® or placebo for 8 days. Children receiving KalobaTUSS® showed an early and significant reduction in night-time and day-time cough scores measured using a specific scale and a shorter duration of cough than children treated with the placebo.<bold>Conclusions: </bold>KalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.<bold>Trial Registration: </bold>Clinicaltrials.gov no. NCT04073251 . Retrospectively registered. [ABSTRACT FROM AUTHOR]