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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
History of Changes
  Purpose

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.


Condition Intervention
Acute Otitis Media
 Drug: Hyland's earache drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ear Drops for Children With Otitis Media

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Side Effects of Therapy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
homeopathic ear drops in addition to standard care for otitis media
 Drug: Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days
No Intervention: 2
No ear drops, standard care for otitis

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622518

Locations
United States, Washington
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Standard Homeopathic Company
Investigators
Principal Investigator: James A Taylor University of Washington
  More Information

No publications provided

Responsible Party: James A. Taylor, MD, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00622518     History of Changes
Other Study ID Numbers: 33097-B, 07-9092-B 01
Study First Received: February 13, 2008
Results First Received: September 28, 2010
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
otitis media
children

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013