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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 Media

Administration 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

Page last updated: August 23, 2015

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