Clinical Trial: Homeopathic Ear Drops for Otitis Media Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Homeopathic Ear Drops for Children With Otitis Media Study

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 in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 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.

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome:

  • Severity of Symptoms of Otitis Media [ Time Frame: 15 days ]
  • Administration of Antibiotics [ Time Frame: 15 days ]
    Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.


Original Primary Outcome:

  • Severity of Symptoms of Otitis Media [ Time Frame: 15 days ]
  • Administration of Antibiotics [ Time Frame: 15 days ]


Current Secondary Outcome: Side Effects From Study Remedy [ Time Frame: 15 days ]

Any "other symptoms" reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone.


Original Secondary Outcome: Side Effects From Study Remedy [ Time Frame: 15 days ]

Information By: University of Washington

Dates:
Date Received: October 26, 2009
Date Started: October 2009
Date Completion:
Last Updated: July 23, 2014
Last Verified: July 2014