Homeopathic Ear Drops for Otitis Media Study

Study Overview
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Brief Summary
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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.

Official Title
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Homeopathic Ear Drops for Children With Otitis Media Study

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: Hyland's earache drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathic ear drops<br>Commercially available homeopathic ear drops | Drug: Hyland's earache drops<br>* 3-4 drops in affected ear 3 times a day as needed for up to 5 days<br>|
| No Intervention: standard therapy<br>standard therapy for otitis media, no ear drops | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otitis media, children, homeopathy