COM-13-00

About this trial

Last updated 8 years ago

Study ID

COM-13-00

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

2 to 5 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 11 years ago

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 carbocysteine syrup usually used to treat children (Syr Mucolit).

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 carbocysteine specifically to the comparator Mucolit

- gastric ulcer

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