A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection

Cough Clinical Trial

Official title: A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection

Status Terminated

Clinical Trial Summary

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. A product that has been used in alternative medicine for cough is maple syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some relief from cough in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo, should provide superior relief on nocturnal cough and the sleep difficulty associated with URI in children under 12 months and sleep difficulty of their parent/caregiver.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough
• Infection
• Nocturnal Cough
• Respiratory Tract Infections
• Upper Respiratory Infection

• NCT number: NCT01588249
• Study type: Interventional
• Source: Zarbee's Inc.
• Status: Terminated
• Phase: N/A
• Start date: April 2012
• Completion date: June 2012