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Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children. (URTI)

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ClinicalTrials.gov Identifier: NCT01968434
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : November 2, 2015
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Aboca Spa Societa' Agricola
Information provided by (Responsible Party):
Avner Herman Cohen, Clalit Health Services

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cough
Upper Respiratory Tract Infection
Interventions: Device: protective cough syrup
Drug: carbocisteine cough syrup

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruiting took place within the Clalit health service community day hospitals. Community day hospitals are places where parents go for usual illnesses and treat most community ailments.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21)

Reporting Groups
  Description
Protective Cough Syrup

syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.

Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)

protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.

Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0

Carbocisteine Cough Syrup

Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

carbocisteine cough syrup: Mucolytic

Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0


Participant Flow:   Overall Study
    Protective Cough Syrup   Carbocisteine Cough Syrup
STARTED   78   72 
COMPLETED   75   66 
NOT COMPLETED   3   6 
Lost to Follow-up                3                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled patients had a minimum cough intensity both day and night, according to questionnaire, had not received any cough medicine the day before enrollment and fulfilled all inclusion criteria.

Reporting Groups
  Description
Protective Cough Syrup

syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.

Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)

protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.

Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0

Carbocisteine Cough Syrup

Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

carbocisteine cough syrup: Mucolytic

Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0

Total Total of all reporting groups

Baseline Measures
   Protective Cough Syrup   Carbocisteine Cough Syrup   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   72   150 
Age 
[Units: Months]
Mean (Standard Deviation)
 42.49  (12.96)   43.17  (14.57)   42.8  (13.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  52.6%      38  52.8%      79  52.7% 
Male      37  47.4%      34  47.2%      71  47.3% 
Region of Enrollment 
[Units: Participants]
     
Israel   78   72   150 
Participants coughing since ≥ 3 days at time of enrollment 
[Units: Participants]
 47   46   93 


  Outcome Measures

1.  Primary:   Change in Night Cough Score on First Night of Treatment (From N0 to N1)   [ Time Frame: 1 night from before enrollment (N0) to first night after treatment (N1) ]

2.  Secondary:   Change in Night Cough Score at End of Study (From N0 to N4)   [ Time Frame: 4 nights (onset of trial Night 1 to Night 4) and 3 days ]

3.  Secondary:   Change in Day Cough Score at End of Study (From D0 to D4)   [ Time Frame: 4 nights (onset of trial Night 1 to Night 4) and 3 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Herman Avner Cohen
Organization: Clalit HS
phone: 00972 3-939-8203
e-mail: hermanc@clalit.org.il


Publications:
Department of child and adolescent health. Cough and cold remedies for the treatment of acute respiratory infections in young children. Geneva, Switzerland: World Health Organization: 2001.
Kraft K. Efficacy of fluid in Plantago lanceolata extract (PLFE) in acute respiratory disease. Phytomedicine, Supplement 1, 1996


Responsible Party: Avner Herman Cohen, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01968434     History of Changes
Other Study ID Numbers: COM-13-00
First Submitted: October 17, 2013
First Posted: October 24, 2013
Results First Submitted: May 14, 2015
Results First Posted: November 2, 2015
Last Update Posted: February 23, 2018