Efficacy and tolerability of SEDIFLÙ in treating dry or productive cough in the pediatric population (SEPEDIA): A pilot, randomized, double-blind, placebo-controlled, multicenter clinical trial

Author:

Núñez Carlos1,Chiatti María Cristina2,Tansella Francesco3,Coronel-Rodríguez Cristóbal4,Risco Ester5ORCID

Affiliation:

1. Pediatría Dr. Carlos Núñez de Prado Aparicio, Madrid, Spain

2. Consultorio local de Brunete, Madrid, Spain

3. Pediatric Infectious Diseases, Giovanni XXIII Children’s Hospital, Bari, Italy

4. Centro de Salud Amante Laffón, Distrito de Atención Primaria Sevilla, Servicio Andaluz de Salud, Sevilla, Spain

5. Unitat de Farmacologia, Farmacognòsia i Terapèutica, Facultat de Farmàcia, Universitat de Barcelona, Barcelona, Spain

Abstract

The aim of this trial was to assess the effectiveness of Sediflù, a medical device containing active herbal ingredients, on nocturnal and diurnal persistent coughs in children, with a duration of 3 to 7 days. Children with a dry and/or productive cough were enrolled in this prospective, interventional, multicenter, placebo-controlled, double-blind, randomized clinical study. Clinical efficacy was assessed through the evaluation of the soothing action of Sediflù against dry and/or productive coughing, both at night and during the day, and other effects of coughing associated with quality of sleep: frequency, child’s quality of sleep, parental quality of sleep and severity. Treatment with Sediflù improved both night-time and day-time cough scores from day 2. The diurnal score also improved significantly in the Sediflù group at days 3 and 7. Sediflù syrup can be considered a valid treatment for cough management in younger children with upper respiratory tract infections, shortening the cough duration.

Funder

Cinfa Laboratories

Publisher

SAGE Publications

Reference33 articles.

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