Ear Drops for Children With Otitis Media - Full Text View

Sponsor:	University of Washington
Collaborator:	Standard Homeopathic Company
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00622518

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Ear Drops for Children With Otitis Media

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Carbamide Carbamide peroxide

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Resolution of Otitis Media Symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	6 Months to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622518

Locations

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

Investigators

Principal Investigator:

James A Taylor

University of Washington

More Information

No publications provided

Responsible Party:	James A. Taylor, MD, Professor, University of Washington
ClinicalTrials.gov 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
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

otitis media
children

Additional relevant MeSH terms:

Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 13, 2012