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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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ClinicalTrials.gov Identifier: NCT02486835
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Avner Herman Cohen, Clalit Health Services

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.

Condition or disease Intervention/treatment Phase
Cough Device: Cough syrup for adults and children Device: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Actual Study Start Date : December 23, 2015
Actual Primary Completion Date : April 3, 2016
Actual Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold Cough

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 Name: 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




Primary Outcome Measures :
  1. Change in night cough frequency score in the general population [ Time Frame: baseline up to night 1 ]
    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 :
  1. Change in night cough frequency score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  2. Change in night cough frequency score in the female population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  3. Change in night cough frequency score in the male population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  4. Change in night cough severity score in the general population [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  5. Change in night cough severity score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  6. Change in night cough bothersomeness score in the general population [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  7. Change in night cough bothersomeness score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  8. Change in night cough influence on sleep of child score in the general population [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  9. Change in night cough influence on sleep of child score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  10. Change in night cough influence on sleep of parent score in the general population [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  11. Change in night cough influence on sleep of parent score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  12. Change in night cough combined score in the general population [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  13. Change in night cough combined score in the population coughing since 1-2 days [ Time Frame: baseline up to night 1 ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents

  14. Change in day cough frequency score in the general population [ Time Frame: baseline up to day 2 ]

    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.




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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486835


Locations
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Israel
Pediatric Ambulatory Clinic Bat-Yam
Bat Yam, Israel
Pediatric Ambulatory Clinic Kfar-Saba
Kfar Saba, Israel
Pediatric Community Ambulatory Clinic - Petach-Tikva
Petaẖ Tiqwa, Israel
Pediatric Ambulatory Clinic Ramat Aviv Gimel
Tel Aviv, Israel
Sponsors and Collaborators
Clalit Health Services
Investigators
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Principal Investigator: Herman A Cohen, Prof. Clalit HS
Publications:

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Responsible Party: Avner Herman Cohen, Prof. Herman Avner Cohen, Clalit Health Services
ClinicalTrials.gov Identifier: NCT02486835    
Other Study ID Numbers: ABO-cough-2015
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Common Cold
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Respiratory Tract Infections
Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases