Otitis Media Clinical Trial
Official title:
Homeopathic Ear Drops for Children With Otitis Media Study
NCT number | NCT01003210 |
Other study ID # | 37011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | December 2013 |
Verified date | May 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 210 |
Est. completion date | December 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 11 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mercer Island Pediatric Associates | Mercer Island | Washington |
United States | Valley Children's Clinic | Renton | Washington |
United States | University of Washington Medical Center-Roosevelt Pediatric Care Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Symptoms of Otitis Media | Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment | 15 days | |
Primary | Administration of Antibiotics | Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit. | 15 days | |
Secondary | Side Effects From Study Remedy | Any "other symptoms" reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone. | 15 days |
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