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

Not Applicable

Terminated

• Conditions: Cough; Upper Respiratory Infection; Nocturnal Cough
• Interventions: Dietary Supplement: Pasteurized maple syrup; Dietary Supplement: Placebo

• Registration Number: NCT01588249
• Lead Sponsor: Zarbee's Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel formulation of pasteurized maple cough syrup	Pasteurized maple syrup	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in cough frequency between the first night and the end of the second night.	baseline and day 2

Trial Locations

Locations (3)

Families First Pediatrics; 🇺🇸 South Jordan, Utah, United States

Willow Creek Pediatrics; 🇺🇸 Draper, Utah, United States

Southwest Children's Clinic; 🇺🇸 West Jordan, Utah, United States