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

BackgroundAcute 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.MethodsWe conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS (R), 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.ResultsChildren were orally treated with KalobaTUSS (R) or placebo for 8 days. Children receiving KalobaTUSS (R) 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.ConclusionsKalobaTUSS (R) is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.Trial registrationClinicaltrials.gov no. NCT04073251. Retrospectively registered.