Clinical Trial: Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparative Efficacy of the Suppository Composed by Guaiacol, Eucalyptol, Menthol and Camphor Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Coug

Brief Summary: It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.

Detailed Summary:
Sponsor: Azidus Brasil

Current Primary Outcome: Improvement of cough of infectious origin. [ Time Frame: 7 days of treatment. ]

During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.


Original Primary Outcome: Improvement of cough of infectious origin [ Time Frame: 1, 3 and 7 days ]

Current Secondary Outcome: Analysis of parameters for the improvement of infectious cough. [ Time Frame: 7 days of treatment. ]

During visits (V1, V2, V3 and V4) will be assessed the signs of improvement in difficulty in breathing,quality of sleep,nasal obstruction, food intake and adherence to the treatment.


Original Secondary Outcome:

  • Difficulty in breathing [ Time Frame: 1, 3 and 7 days ]
  • Quality of sleep [ Time Frame: 1, 3 and 7 days ]
  • Nasal obstruction [ Time Frame: 1, 3 and 7 days ]
  • Food intake [ Time Frame: 1, 3 and 7 days ]
  • Adherence to the treatment [ Time Frame: 1, 3 and 7 days ]


Information By: Azidus Brasil

Dates:
Date Received: April 29, 2010
Date Started: May 2011
Date Completion: December 2011
Last Updated: January 27, 2011
Last Verified: January 2011