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Completed

NCT Number: NCT01003210

Homeopathic Ear Drops for Otitis Media Study

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercer Island Pediatric Associates, Mercer Island, Washington, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 6 months - 11 years old
  • Diagnosed with otitis media by clinician at participating clinic
  • Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management

Exclusion criteria

  • Antibiotic treatment during past 7 days
  • Homeopathic treatment within past 30 days
  • History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis
  • Perforated tympanic membrane
  • Immediate antibiotic treatment plan decided by examining clinician

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. Severity of Symptoms of Otitis Media

    Time frame: 15 days

    Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Homeopathic Ear Drops for Children With Otitis Media Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2009
Registry last updated
Jun 8, 2018

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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