Homeopathic Ear Drops for Otitis Media Study
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media
Intervention: Hyland's earache drops (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): James A Taylor, MD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Homeopathic Ear Drops for Children With Otitis Media Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Severity of Symptoms of Otitis MediaAdministration of Antibiotics
Secondary outcome: Side Effects From Study Remedy
Eligibility
Minimum age: 6 Months.
Maximum age: 11 Years.
Gender(s): Both.
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
Locations and Contacts
Mercer Island Pediatric Associates, Mercer Island, Washington 98040, United States
Valley Children's Clinic, Renton, Washington 98055, United States
University of Washington Medical Center-Roosevelt Pediatric Care Center, Seattle, Washington 98195, United States
Additional Information
Starting date: October 2009
Last updated: July 23, 2014
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