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The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.
The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
STUDY DESIGN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days |
|
| Comparator group | Active Comparator | Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naphazoline hydrocloride | Drug | 02 drops into each nostril, 04 times a day for 03 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay | The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by the Adverse events occurence | Adverse events will be collected and followed in order to evaluate safety and tolerability | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Naphazoline hydrocloride + Pheniramine Maleate + Panthenol |
| Drug |
02 drops into each nostril each 12 hours for 03 days |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
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| ID | Term |
|---|---|
| D010632 | Pheniramine |
| C007288 | dexpanthenol |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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