Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01968434
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT01968434
Study Brief:
Protocol Section:
NCT01968434