Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

Cough Clinical Trial

Official title: A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection

Status Not yet recruiting

Clinical Trial Summary

The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days due to common cold respond to a specific protective cough syrup taken before going to bed for one night, with respect to a similar but not specific syrup (placebo). The symptoms evaluated include especially cough frequency but also cough intensity, bother, and sleep quality of the child and parents.

Clinical Trial Description

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results. A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has been looked at specifically on the clinically critical population of children coughing since 1-2 days and not more, including very young children of one year old. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. Daily cough is assessed to better describe and select the general condition of the child however only night cough parameters due to treatment are assessed. The degree of disturbance of cough is followed immediately after one night administration on all night parameters, with special interest to frequency.

Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy. The study looks at the effect of the syrup/placebo on the first night in order to well focus the "first" effect of a treatment on the ascending phase of the illness, such as to reduce to a minimum any interference due to natural regression of the symptom due to illness progression. ;

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection
• Cough
• Infection
• Respiratory Tract Infections

• NCT number: NCT03218696
• Study type: Interventional
• Source: Clalit Health Services
• Contact: Herman A Cohen, Prof.
• Phone: + 972-3- 9398203
• Email: hermanc@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2018
• Completion date: December 2018