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

Phase

N/A

Condition

Acute Rhinitis

Common Cold

Treatment

N/A

Clinical Study ID

NCT02486835

ABO-cough-2015

Ages 1-5
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 tonight cough, frequency of nocturnal cough, impact on sleep of child and impact onsleep of parent,
score of at least three of all questions assessing daytime cough considering the dayprior to study entry
written consent by a parent.

Exclusion

Exclusion Criteria:

Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma,sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosisor any anatomical respiratory tract anomalies,
Children who received antihistamines or any cough medicine the day prior to studyentry,
The administration of any steroid preparation by oral administration or inhalation onthe day prior to study entry,
Known sensitivity to any component of placebo or to Plantago lanceolata or Thymusvulgaris, honey or any other component of the cough syrup.

Study Design

December 23, 2015

April 06, 2016

Study 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 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.

Connect with a study center

Pediatric Ambulatory Clinic Bat-Yam
Bat Yam,
Israel
Site Not Available
Pediatric Ambulatory Clinic Kfar-Saba
Kfar Saba,
Israel
Site Not Available
Pediatric Community Ambulatory Clinic - Petach-Tikva
Petach-Tikva,
Israel
Site Not Available
Pediatric Community Ambulatory Clinic - Petach-Tikva
Petaẖ Tiqwa,
Israel
Site Not Available
Pediatric Ambulatory Clinic Ramat Aviv Gimel
Tel Aviv,
Israel
Site Not Available

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