Ear Drops for Children With Otitis Media

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. Identifier: NCT00622518
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : December 2, 2010
Last Update Posted : December 2, 2010
Standard Homeopathic Company
Information provided by:
University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Otitis Media Drug: Hyland's earache drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ear Drops for Children With Otitis Media
Study Start Date : February 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Resolution of Otitis Media Symptoms [ Time Frame: 5 days ]
    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 :
  1. Side Effects of Therapy [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00622518

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
Principal Investigator: James A Taylor University of Washington

Responsible Party: James A. Taylor, MD, Professor, University of Washington Identifier: NCT00622518     History of Changes
Other Study ID Numbers: 33097-B
07-9092-B 01
First Posted: February 25, 2008    Key Record Dates
Results First Posted: December 2, 2010
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by University of Washington:
otitis media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases