Ear Drops for Children With Otitis Media

This study has been completed.
Sponsor:
Collaborator:
Standard Homeopathic Company
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00622518
First received: February 13, 2008
Last updated: November 4, 2010
Last verified: November 2010

February 13, 2008
November 4, 2010
February 2008
February 2009   (final data collection date for primary outcome measure)
Resolution of Otitis Media Symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
resolution of otitis media symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622518 on ClinicalTrials.gov Archive Site
Side Effects of Therapy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ear Drops for Children With Otitis Media
Ear Drops for Children With Otitis Media

The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Acute Otitis Media
Drug: Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days
  • Active Comparator: 1
    homeopathic ear drops in addition to standard care for otitis media
    Intervention: Drug: Hyland's earache drops
  • No Intervention: 2
    No ear drops, standard care for otitis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
April 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presenting to participating clinic with otitis media
  • Diagnosed with acute otitis media
  • Parents rate symptoms as a "moderate problem" or more

Exclusion Criteria:

  • Diagnosis of otitis media within preceding 30 days
  • Receipt of antibiotics within 2 days
  • Perforated ear drum or bullous lesion
  • Receipt of homeopathic treatment within 30 days
Both
6 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622518
33097-B, 07-9092-B 01
Yes
James A. Taylor, MD, Professor, University of Washington
University of Washington
Standard Homeopathic Company
Principal Investigator: James A Taylor University of Washington
University of Washington
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP