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Cough | Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.

Cough research study

What is the primary objective of this study?

The purpose of this study is to determine if there is comparable efficacy between carbocisteine and a protective cough syrup from natural ingredients in children's cough due to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that protecting the throat is very useful in decreasing cough severity, both day and night, without needing to subdue such an important reflex as cough, and without only acting on mucous fluidification, especially in children where sedation and excessive fluidification is dangerous. The research hypothesis is that the protective (GrinTuss) Syrup relieves cough (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the quality of sleep of the child) as much as or more than the carbocisteine syrup usually used to treat children (Syr Mucolyt).

Who is eligible to participate?

Inclusion Criteria: - cough attributed to URTI such as the common cold - 2-5 years of age - moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment. - moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent) - signature of informed consent Exclusion Criteria: - Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease. - Children who received cough medicines or drugs containing antihistamines the day prior to study entry. - Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring - Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry ) - Known sensitivity to carbocisteine specifically to the comparator Mucolyt - gastric ulcer

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cough

Upper Respiratory Tract Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:protective cough syrupThe 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.

Drug:carbocisteine cough syrupMucolytic

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

protective cough syrupsyrup 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: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)

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

Study Status

Completed

Start Date: December 2013

Completed Date: April 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in Night Cough Score on First Night of Treatment (From N0 to N1)

Secondary Outcome: Change in Night Cough Score at End of Study (From N0 to N4)

Study sponsors, principal investigator, and references

Principal Investigator: Herman Avner Cohen, Professor

Lead Sponsor: Clalit Health Services

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01968434

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

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