Homeopathic Ear Drops for Otitis Media Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003210
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : July 22, 2014
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
James Taylor, 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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Hyland's earache drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Homeopathic Ear Drops for Children With Otitis Media Study
Study Start Date : October 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Homeopathic ear drops
Commercially available homeopathic ear drops
Drug: Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days

No Intervention: standard therapy
standard therapy for otitis media, no ear drops

Primary Outcome Measures :
  1. Severity of Symptoms of Otitis Media [ Time Frame: 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

  2. Administration of Antibiotics [ Time Frame: 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.

Secondary Outcome Measures :
  1. Side Effects From Study Remedy [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003210

United States, Washington
Mercer Island Pediatric Associates
Mercer Island, Washington, United States, 98040
Valley Children's Clinic
Renton, Washington, United States, 98055
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: James A Taylor, MD University of Washington

Responsible Party: James Taylor, Professor, University of Washington Identifier: NCT01003210     History of Changes
Other Study ID Numbers: 37011
First Posted: October 28, 2009    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: June 8, 2018
Last Verified: May 2018

Keywords provided by James Taylor, University of Washington:
otitis media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases