N/A
N=210
Homeopathic Ear Drops for Otitis Media Study
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01003210 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Severity of Symptoms of Otitis Media — 2.0; 2.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyland's earache drops (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Symptoms of Otitis Media |
2.0; 2.0 | — |
| PRIMARY Administration of Antibiotics |
28; 42 | — |
| SECONDARY Side Effects From Study Remedy |
4; 5; 3; 11; 5; 6 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01003210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.