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Homeopathic Ear Drops for Otitis Media Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Taylor, University of Washington
ClinicalTrials.gov Identifier:
NCT01003210
First received: October 26, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention
Otitis Media
Drug: Hyland's earache drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Homeopathic Ear Drops for Children With Otitis Media Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Severity of Symptoms of Otitis Media [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Administration of Antibiotics [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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:
  • Side Effects From Study Remedy [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 210
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003210

Locations
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
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

No publications provided

Responsible Party: James Taylor, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01003210     History of Changes
Other Study ID Numbers: 37011-B
Study First Received: October 26, 2009
Results First Received: May 19, 2014
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
otitis media
children
homeopathy

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014