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 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.

Fig. 1

Study Flowchart

Fig. 2

Night-time or Day-time cough score before and after treatment with KalobaTUSS® or placebo. * = p < 0.05 vs placebo; * = p < 0.01 vs placebo

Fig. 3

Reduction in night-time and day-time cough scores in children treated with KalobaTUSS® or Placebo. * = p < 0.01 vs Placebo