Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Primary Purpose
Cough
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cough syrup for adults and children
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cough
Eligibility Criteria
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.
Sites / Locations
- Pediatric Ambulatory Clinic Bat-Yam
- Pediatric Ambulatory Clinic Kfar-Saba
- Pediatric Community Ambulatory Clinic - Petach-Tikva
- Pediatric Ambulatory Clinic Ramat Aviv Gimel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
"Cough Syrup for adults and children"
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02486835
Brief Title
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Official Title
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 23, 2015 (Actual)
Primary Completion Date
April 3, 2016 (Actual)
Study Completion Date
April 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Cough Syrup for adults and children"
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cough syrup for adults and children
Other Intervention Name(s)
Poliflav M.A.-honey cough syrup
Intervention Description
Dosage is 5 ml three times a day for 4 nights, 3 days
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Dosage is 5 ml three times a day for 4 nights, 3 days
Primary Outcome Measure Information:
Title
Change in night cough frequency score in the general population
Description
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.
Time Frame
baseline up to night 1
Secondary Outcome Measure Information:
Title
Change in night cough frequency score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough frequency score in the female population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough frequency score in the male population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough severity score in the general population
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough severity score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough bothersomeness score in the general population
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough bothersomeness score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough influence on sleep of child score in the general population
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough influence on sleep of child score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough influence on sleep of parent score in the general population
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough influence on sleep of parent score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough combined score in the general population
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in night cough combined score in the population coughing since 1-2 days
Description
All these other elements constitute cough invasiveness into the quality of life of child and parents
Time Frame
baseline up to night 1
Title
Change in day cough frequency score in the general population
Description
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.
Time Frame
baseline up to day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman A Cohen, Prof.
Organizational Affiliation
Clalit HS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Ambulatory Clinic Bat-Yam
City
Bat Yam
Country
Israel
Facility Name
Pediatric Ambulatory Clinic Kfar-Saba
City
Kfar Saba
Country
Israel
Facility Name
Pediatric Community Ambulatory Clinic - Petach-Tikva
City
Petaẖ Tiqwa
Country
Israel
Facility Name
Pediatric Ambulatory Clinic Ramat Aviv Gimel
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16841784
Citation
Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.
Results Reference
background
PubMed Identifier
15231978
Citation
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.
Results Reference
background
PubMed Identifier
18056558
Citation
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.
Results Reference
background
PubMed Identifier
10483683
Citation
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.
Results Reference
background
PubMed Identifier
24917119
Citation
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.
Results Reference
background
PubMed Identifier
18676517
Citation
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.
Results Reference
background
PubMed Identifier
12617614
Citation
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.
Results Reference
background
PubMed Identifier
19155427
Citation
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.
Results Reference
background
PubMed Identifier
22869830
Citation
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.
Results Reference
background
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Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
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