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Ear Drops for Children With Otitis Media

This study has been completed.
Standard Homeopathic Company
Information provided by:
University of Washington Identifier:
First received: February 13, 2008
Last updated: November 4, 2010
Last verified: November 2010
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ear Drops for Children With Otitis Media

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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:
  • Side Effects of Therapy [ Time Frame: 5 days ]

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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: February 13, 2008
Results First Received: September 28, 2010
Last Updated: November 4, 2010

Keywords provided by University of Washington:
otitis media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases processed this record on September 19, 2017