Ear Drops for Children With Otitis Media

Not Applicable

Completed

• Conditions: Acute Otitis Media
• Interventions: Drug: Hyland's earache drops

• Registration Number: NCT00622518
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Results First Submitted: 2010-09-28
• Status Verified: 2010-11
• Results First Submitted QC: 2010-11-04
• Last Update Submitted: 2010-11-04
• Results First Posted: 2010-12-02
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Presenting to participating clinic with otitis media
• Diagnosed with acute otitis media
• Parents rate symptoms as a "moderate problem" or more

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hyland's earache drops	homeopathic ear drops in addition to standard care for otitis media

Primary Outcome Measures

Name	Time	Method
Resolution of Otitis Media Symptoms	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

Name	Time	Method
Side Effects of Therapy	5 days

Trial Locations

Locations (1)

University of Washington Medical Center-Roosevelt Pediatric Care Center; 🇺🇸 Seattle, Washington, United States