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

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