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.

Background: Persistent cough in children often causes discomfort to children and parents reducing their quality of life. In spite of the extensive utilization of over the counter remedies against cough, for most of them efficacy in children has not been demonstrated. Methods: We conducted a randomized, double blind, placebo-controlled clinical trial recruiting 106 children with persistent cough to evaluate the efficacy and safety of KalobaTUSS®, a pediatric cough syrup based on acacia honey and on moieties derived from Malva sylvestris extract, Inula helenium, Plantago major extract, Helichrysum stoechas. Results: Children were orally treated with KalobaTUSS® or placebo for eight days. Children receiving KalobaTUSS® showed an early significant reduction in night-time and day-time cough score measured through a specific scale and a shorter duration of cough in comparison to placebo. Conclusions: Results show that KalobaTUSS® is well tolerated and produces positive effects by reducing severity and shortening the duration of cough in children. (Clinicaltrials.gov n. NCT04073251).

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 eight 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.

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 from Malva sylvestris, Inula helenium, Plantago major extract, and Helichrysum stoechas extracts.Results: Children were orally treated with KalobaTUSS® or placebo for eight 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 (Clinicaltrials.gov no. NCT04073251).

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 eight 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 (Clinicaltrials.gov no. NCT04073251).