Ilaria Carnevali1, Rita La Paglia2, Lara Pauletto1, Floriana Raso1, Marco Testa1, Carmen Mannucci3, Emanuela Elisa Sorbara3, Gioacchino Calapai4. 1. Scientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy. 2. Pediatrician, Azienda Sanitaria Provinciale 5, Messina, Italy. 3. Department of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, Via Consolare Valeria n 1, 98125, Messina, Italy. 4. Department of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, Via Consolare Valeria n 1, 98125, Messina, Italy. gcalapai@unime.it.
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.
RCT Entities:
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.
Authors: Alessandro Zanasi; Luigi Morcaldi; Salvatore Cazzato; Massimiliano Mazzolini; Marzia Lecchi; Antonio Maria Morselli-Labate; Marianna Mastroroberto; Roberto W Dal Negro Journal: Clinicoecon Outcomes Res Date: 2017-03-16