Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

Clalit Health Services150 enrolled

Overview

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. Cough is assessed with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

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 not been done so far, in very young children, especially in a time frame of 4 days. 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. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days. Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Interventions

Cough syrup for adults and childrenDEVICE

Dosage is 5 ml three times a day for 4 nights, 3 days

PlaceboDEVICE

Dosage is 5 ml three times a day for 4 nights, 3 days

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * cough attributed to infection of the upper respiratory tract since less or equal than 7 days, * children aged 1 to 5 years * score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent, * score of at least three of all questions assessing daytime cough considering the day prior to study entry * written consent by a parent. Exclusion Criteria: * Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies, * Children who received antihistamines or any cough medicine the day prior to study entry, * The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry, * Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the cough syrup.

Locations (4)

Pediatric Ambulatory Clinic Bat-Yam

Bat Yam, Israel

Pediatric Ambulatory Clinic Kfar-Saba

Kfar Saba, Israel

Pediatric Community Ambulatory Clinic - Petach-Tikva

Petah Tikva, Israel

Pediatric Ambulatory Clinic Ramat Aviv Gimel

Tel Aviv, Israel

Outcomes

Primary Outcomes

Change in night cough frequency score in the general population

Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in each morning relating to the passed night for four nights. The basal night score is the score of the night before enrollment.