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Homeopathic Ear Drops for Otitis Media Study

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyland's earache drops
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Otitis Media focused on measuring otitis media, children, homeopathy

Eligibility Criteria

6 Months - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercer Island Pediatric Associates
  • Valley Children's Clinic
  • University of Washington Medical Center-Roosevelt Pediatric Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Homeopathic ear drops

standard therapy

Arm Description

Commercially available homeopathic ear drops

standard therapy for otitis media, no ear drops

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 26, 2009
Last Updated
May 8, 2018
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01003210
Brief Title
Homeopathic Ear Drops for Otitis Media Study
Official Title
Homeopathic Ear Drops for Children With Otitis Media Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
otitis media, children, homeopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Homeopathic ear drops
Arm Type
Experimental
Arm Description
Commercially available homeopathic ear drops
Arm Title
standard therapy
Arm Type
No Intervention
Arm Description
standard therapy for otitis media, no ear drops
Intervention Type
Drug
Intervention Name(s)
Hyland's earache drops
Intervention Description
3-4 drops in affected ear 3 times a day as needed for up to 5 days
Primary Outcome Measure Information:
Title
Severity of Symptoms of Otitis Media
Description
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
Time Frame
15 days
Title
Administration of Antibiotics
Description
Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Side Effects From Study Remedy
Description
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.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercer Island Pediatric Associates
City
Mercer Island
State/Province
Washington
ZIP/Postal Code
98040
Country
United States
Facility Name
Valley Children's Clinic
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
University of Washington Medical Center-Roosevelt Pediatric Care Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Homeopathic Ear Drops for Otitis Media Study

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