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

NCT02486835 | Completed

• 1 other identifier: ABO-cough-2015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in night cough frequency score in the population coughing since 1-2 days

  baseline up to night 1

• Change in night cough frequency score in the female population coughing since 1-2 days

  baseline up to night 1

• Change in night cough frequency score in the male population coughing since 1-2 days

  baseline up to night 1

• Change in night cough severity score in the general population

  baseline up to night 1

• Change in night cough severity score in the population coughing since 1-2 days

  baseline up to night 1

Study Arms (2)

"Cough Syrup for adults and children"

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Cough syrup for adults and children DEVICE

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

Also known as: Poliflav M.A.-honey cough syrup

"Cough Syrup for adults and children"

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (4)

Pediatric Ambulatory Clinic Bat-Yam

Bat Yam, Israel

Location

Pediatric Ambulatory Clinic Kfar-Saba

Kfar Saba, Israel

Location

Pediatric Community Ambulatory Clinic - Petach-Tikva

Petah Tikva, Israel

Location

Pediatric Ambulatory Clinic Ramat Aviv Gimel

Tel Aviv, Israel

Location

Related Publications (9)

• Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.

  PMID: 16841784 BACKGROUND

• 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.

  PMID: 15231978 BACKGROUND

• 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.

  PMID: 18056558 BACKGROUND

• 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.

  PMID: 10483683 BACKGROUND

• 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.

  PMID: 24917119 BACKGROUND

• 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.

  PMID: 18676517 BACKGROUND

• 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.

  PMID: 12617614 BACKGROUND

• 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.

  PMID: 19155427 BACKGROUND

• 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.

  PMID: 22869830 BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Herman A Cohen, Prof.

  Clalit HS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Herman Avner Cohen

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: July 1, 2015
• Study Start: December 23, 2015
• Primary Completion: April 3, 2016
• Study Completion: April 6, 2016
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

IL (4)