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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03218696
• Date of registration: 12/07/2017
• Prospective Registration: Yes
• Primary sponsor: Clalit Health Services
• Public title: 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
• Scientific 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
• Date of first enrolment: February 2018
• Target sample size: 80
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03218696
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Herman A Cohen, Prof.

• Name: Herman A Cohen, Prof.
• Affiliation: Clalit Health Services

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Cough attributed to infection of the upper respiratory tract present in the child for
not more than 2 days.

2. Children aged 1 year to 5 (ie: 1 day before the 6th birthday, males and females)

3. Score of at least 3 to two of the following three questions relating to the evaluation
of night cough: frequency of nocturnal cough, impact on the sleep of the child and
impact on the sleep of the parent,

4. Score of at least 3 to all three questions assessing "daytime" cough considering the
day prior to study entry.

5. Written signed consent by a parent.

Exclusion Criteria:

- 1. 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.

2. Children who received antihistamines or any cough medicine the day prior to study
entry.

3. The administration of any steroid preparation by oral administration or inhalation
on the day prior to study entry.

4. Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus
vulgaris, honey or any other component of the "Poliflav M.A.-honey cough syrup".



Age minimum: 1 Year
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Upper Respiratory Tract Infection

Cough

Intervention(s)

Device: Placebo

Device: Cough Syrup for adults and children

Primary Outcome(s)

Night cough frequency score reduction [Time Frame: First and only night of treatment]

Secondary Outcome(s)

night cough bothersomeness score reduction [Time Frame: First and only night of treatment]

reduction of influence of cough on combined night score [Time Frame: First and only night of treatment]

night cough intensity score reduction [Time Frame: First and only night of treatment]

reduction of influence of cough on child sleep score [Time Frame: First and only night of treatment]

reduction of influence of cough on parent sleep score [Time Frame: First and only night of treatment]

Secondary ID(s)

COM-17-0096

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aboca Spa Societa' Agricola