CClinicalTrials.gg
CompletedNCT00743990Updated Nov 24, 2017

Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

An interventional study of Ointment containing camphor, eucalyptus oil, and menthol and Petroleum jelly in Respiratory Tract Diseases, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 2 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by Penn State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Tract Diseases

Keywords

  • Cough symptoms
  • Cold symptoms
  • Congestion
  • Children
  • URI
  • Alternative cough symptom treatment
03

In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's enrollment of 143 is above the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Cough and congestion attributed to upper respiratory tract infection

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
143 participants (actual)

Study arms

  • Active comparator
    A

    Other: Ointment containing camphor, eucalyptus oil, and menthol

  • Placebo comparator
    B

    Other: Petroleum jelly

  • No intervention
    3

    no intervention

Interventions

  • OtherOintment containing camphor, eucalyptus oil, and menthol

    One time use

  • OtherPetroleum jelly

    One time use

06

What researchers measure

Primary outcomes

  1. Subjective assessment of cough and congestion symptoms

    Time frame: 24 hours

07

Study locations

1 site
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
08

References and documents

Publications

  • Paul IM, Beiler JS, King TS, Clapp ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms. Pediatrics. 2010 Dec;126(6):1092-9. doi: 10.1542/peds.2010-1601. Epub 2010 Nov 8. PubMed 21059712 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00743990
Lead sponsor
Penn State University
Collaborators
Procter and Gamble
Responsible party
Sponsor
First posted
Aug 29, 2008
Start date
Oct 2008
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Nov 24, 2017

Study contacts

Ian M Paul, MD, MSc
principal investigator · Penn State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion