N/A
N=119
Ear Drops for Children With Otitis Media
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT00622518 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Resolution of Otitis Media Symptoms — 14.2; 16.5; 7.5; 14.1 units on a scale — p=.002
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
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Otitis Media Symptoms |
14.2; 16.5; 7.5; 14.1; 6.1; 10.8 | .002 sig |
| SECONDARY Side Effects of Therapy |
29; 37; 5; 10; 3; 5 | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00622518). 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.