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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01588249
Recruitment Status : Terminated (Revisiting product options)
First Posted : April 30, 2012
Last Update Posted : October 11, 2012
Advanced Clinical Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cough Upper Respiratory Infection Nocturnal Cough Dietary Supplement: Pasteurized maple syrup Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Novel formulation of pasteurized maple cough syrup Dietary Supplement: Pasteurized maple syrup
Placebo Comparator: Placebo Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Change from baseline in cough frequency between the first night and the end of the second night. [ Time Frame: baseline and day 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Otherwise healthy male or female infant who is between 0 and 12 months of age.
  2. Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
  3. Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
  4. Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough frequency, effect on child's sleep, and effect on parental/caregiver sleep based on the previous night's symptoms (see Section 11.0).
  5. Parent/legal authorized representative provides written informed consent for child to participate in study.
  6. Parent/caregiver who is willing and able to comply with study requirements.

Exclusion Criteria

  1. Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, sinusitis, allergic rhinitis).
  2. Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
  3. History of reactive airways disease, asthma, or chronic lung disease.
  4. Use of any medication to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. (Use of analgesic medications such as acetaminophen or ibuprofen is not exclusionary.)
  5. Presence of any significant disease including immunodeficiency, hepatic, renal, cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588249

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United States, Utah
Willow Creek Pediatrics
Draper, Utah, United States
Families First Pediatrics
South Jordan, Utah, United States
Southwest Children's Clinic
West Jordan, Utah, United States
Sponsors and Collaborators
Zarbee's Inc.
Advanced Clinical Research
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Responsible Party: Zarbee's Inc.
ClinicalTrials.gov Identifier: NCT01588249    
Other Study ID Numbers: ZMCS-6441
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory