Homeopathic Ear Drops for Otitis Media Study

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Drug: Hyland's earache drops

• Registration Number: NCT01003210
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2013-04
• Study Completion: 2013-12
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-06-24
• Results First Posted: 2014-07-22
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homeopathic ear drops	Hyland's earache drops	Commercially available homeopathic ear drops

Primary Outcome Measures

Name	Time	Method
Administration of Antibiotics	15 days	Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
Severity of Symptoms of Otitis Media	15 days	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

Secondary Outcome Measures

Name	Time	Method
Side Effects From Study Remedy	15 days	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.

Trial Locations

Locations (3)

Valley Children's Clinic; 🇺🇸 Renton, Washington, United States

Mercer Island Pediatric Associates; 🇺🇸 Mercer Island, Washington, United States

University of Washington Medical Center-Roosevelt Pediatric Care Center; 🇺🇸 Seattle, Washington, United States