Background: 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.
Methods: 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.
Results: 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.
Conclusions: KalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.
Trial registration: Clinicaltrials.gov no. NCT04073251 . Retrospectively registered.
Keywords: Children; Cough; Helichrysum stoechas; Honey; Inula helenium; Malva sylvestris; Plantago major; Syrup.