Ear Drops for Children With Otitis Media

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Interventions

  • Drug: Hyland’s earache drops
    • 3-4 drops in affected ear 3 times a day as needed for up to 5 days

Arms, Groups and Cohorts

  • Active Comparator: 1
    • homeopathic ear drops in addition to standard care for otitis media
  • No Intervention: 2
    • No ear drops, standard care for otitis

Clinical Trial Outcome Measures

Primary 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 Measures

  • Side Effects of Therapy
    • Time Frame: 5 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • Standard Homeopathic Company
  • Provider of Information About this Clinical Study
    • James A. Taylor, MD, Professor, University of Washington
  • Overall Official(s)
    • James A Taylor, Principal Investigator, University of Washington

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