Respiratory Tract Diseases
Conditions
Keywords
Cough symptoms, Cold symptoms, Congestion, Children, URI, Alternative cough symptom treatment
Brief summary
This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.
Interventions
OTHEROintment containing camphor, eucalyptus oil, and menthol
One time use
OTHERPetroleum jelly
One time use
Sponsors
Procter and Gamble
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Cough and congestion attributed to upper respiratory tract infection
Exclusion criteria
* Children with signs or symptoms of more serious or treatable disease * Presence of itchy, watery eyes or frequent sneezing * Tachypnea (respiratory rate \>95%ile) or labored breathing * Symptoms for 8 or more days * History of asthma in the past 2 years, chronic lung disease, or seizure disorder * History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective assessment of cough and congestion symptoms | 24 hours |
Countries
United States
Outcome results
None listed