Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Detailed Description
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Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

Official Title
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Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Irlanda-1-Association
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain; Signed Consent of the patient; Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE Exclusion Criteria: Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; Patients with history of hypersensitivity to any of the formula compounds; Participation in clinical trial in the year prior to this study; Patients with vaccine reaction; Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma; Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract; Patients with diabetes mellitus type I and II; Pregnancy or risk of pregnancy and lactating patients; Patients who were in use of drugs that can interfere with flu symptoms evaluation.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irlanda-1-Association<br>For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route. | Drug: Irlanda-1-Association<br>* For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.<br>* Other names: EMS association;|
| Placebo Comparator: Placebo<br>For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route. | Drug: Placebo<br>* For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences |  | 7 days |