Ear Drops for Children With Otitis Media

University of Washington

Status: Completed

Conditions: Acute Otitis Media

Treatments: Drug: Hyland's earache drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00622518

07-9092-B 01

33097-B

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

1

Active Comparator group

Description:

homeopathic ear drops in addition to standard care for otitis media

Treatment:

Drug: Hyland's earache drops

2

No Intervention group

Description:

No ear drops, standard care for otitis