NCT01721395

Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 2 Months – 48 Months
• Healthy volunteers: Not accepted

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. Honey, another method of soothing cough cannot be used in children \<1 year due to concerns for infantile botulism. A preparation from agave syrup has been created to address the need for an infant cough syrup. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.

Conditions

• Cough

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Agave Syrup

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-11-05
• Last updated: 2015-10-23

Locations

1 site across 1 country: United States