This trial is active, not recruiting.

Condition otitis media
Treatment hyland's earache drops
Sponsor University of Washington
Start date October 2009
End date April 2013
Trial size 150 participants
Trial identifier NCT01003210, 37011-B


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Commercially available homeopathic ear drops
hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days
(No Intervention)
standard therapy for otitis media, no ear drops

Primary Outcomes

severity of symptoms of otitis media
time frame: 15 days
Administration of antibiotics
time frame: 15 days

Secondary Outcomes

side effects from study remedy
time frame: 15 days

Eligibility Criteria

Male or female participants from 6 months up to 11 years old.

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

Additional Information

Official title Homeopathic Ear Drops for Children With Otitis Media Study
Principal investigator James A Taylor, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of Washington.