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

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Device: Cough syrup for adults and children; Device: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bat Yam, Israel
    • Pediatric Ambulatory Clinic Bat-Yam
  • Kfar Saba, Israel
    • Pediatric Ambulatory Clinic Kfar-Saba
  • Petaẖ Tiqwa, Israel
    • Pediatric Community Ambulatory Clinic - Petach-Tikva
  • Tel Aviv, Israel
    • Pediatric Ambulatory Clinic Ramat Aviv Gimel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Cough Syrup for adults and children"; Marked (authorized) medical device acting by protecting the oropharynx, in a non pharmacological way, to reduce cough. It contains honey, plantago lanceolata, thymus vulgaris.Dosage form: syrup Dosage: 5 ml three times a day. Frequency: the duration of the study for each patient is 4 nights, 3 days.	Device: Cough syrup for adults and children; Dosage is 5 ml three times a day for 4 nights, 3 days; Other Names: Poliflav M.A.-honey cough syrup
Placebo Comparator: Placebo; The placebo intervention is a syrup of same taste and colour without the protective components. Dosage form: syrup. Dosage: 5 ml three times a day Frequency: the duration of the study for each patient is 4 nights, 3 days.	Device: Placebo; Dosage is 5 ml three times a day for 4 nights, 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline up to night 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in night cough frequency score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough frequency score in the female population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough frequency score in the male population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough severity score in the general population	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough severity score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough bothersomeness score in the general population	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough bothersomeness score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough influence on sleep of child score in the general population	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough influence on sleep of child score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough influence on sleep of parent score in the general population	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough influence on sleep of parent score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough combined score in the general population	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in night cough combined score in the population coughing since 1-2 days	All these other elements constitute cough invasiveness into the quality of life of child and parents	baseline up to night 1
Change in day cough frequency score in the general population	The questionnaire rating day cough is filled in each evening relating to the passed day for three days. The basal day score is the score of the day before enrollment.	baseline up to day 2

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Investigators: Principal Investigator: Herman A Cohen, Prof., Clalit HS

Publications and helpful links

General Publications

• Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, Dilworth DA, Berlin CM Jr. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004 Jul;114(1):e85-90. doi: 10.1542/peds.114.1.e85.
• Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics. 2008 Aug;122(2):e318-22. doi: 10.1542/peds.2007-3813.
• Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.
• Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6. doi: 10.1001/archpedi.161.12.1140.
• Schramm DD, Karim M, Schrader HR, Holt RR, Cardetti M, Keen CL. Honey with high levels of antioxidants can provide protection to healthy human subjects. J Agric Food Chem. 2003 Mar 12;51(6):1732-5. doi: 10.1021/jf025928k.
• Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.
• Bogdanov S, Jurendic T, Sieber R, Gallmann P. Honey for nutrition and health: a review. J Am Coll Nutr. 2008 Dec;27(6):677-89. doi: 10.1080/07315724.2008.10719745.
• Wegener T, Kraft K. [Plantain (Plantago lanceolata L.): anti-inflammatory action in upper respiratory tract infections]. Wien Med Wochenschr. 1999;149(8-10):211-6. German.
• Canciani M, Murgia V, Caimmi D, Anapurapu S, Licari A, Marseglia GL. Efficacy of Grintuss(R) pediatric syrup in treating cough in children: a randomized, multicenter, double blind, placebo-controlled clinical trial. Ital J Pediatr. 2014 Jun 10;40:56. doi: 10.1186/1824-7288-40-56.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2015
• Primary Completion (Actual): April 3, 2016
• Study Completion (Actual): April 6, 2016

Study Registration Dates

• First Submitted: May 17, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Signs and Symptoms, Respiratory; Cough; Common Cold
• Other Study ID Numbers: ABO-cough-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No