Homeopathic Ear Drops for Children With Otitis Media Study

NCT01003210 NA COMPLETED Results posted

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.

Details

Lead sponsor	University of Washington
Phase	NA
Status	COMPLETED
Enrolment	210
Start date	2009-10
Completion	2013-12

Conditions

• Otitis Media

Interventions

• Hyland's earache drops

Primary outcomes

• Severity of Symptoms of Otitis Media — 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
• Administration of Antibiotics — 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.

Countries

United States