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Completed

NCT Number: NCT00622518

Ear Drops for Children With Otitis Media

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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyland's earache drops

Drug

3-4 drops in affected ear 3 times a day as needed for up to 5 days

Primary outcomes

  1. 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 outcomes

  1. Side Effects of Therapy

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Standard Homeopathic Company

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2008
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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