Back to resultsEar Drops for Children With Otitis Media
Primary Purpose
Acute Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyland's earache drops
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Otitis Media focused on measuring otitis media, children
Eligibility Criteria
Inclusion Criteria:
- Presenting to participating clinic with otitis media
- Diagnosed with acute otitis media
- Parents rate symptoms as a "moderate problem" or more
Exclusion Criteria:
- Diagnosis of otitis media within preceding 30 days
- Receipt of antibiotics within 2 days
- Perforated ear drum or bullous lesion
- Receipt of homeopathic treatment within 30 days
Sites / Locations
- University of Washington Medical Center-Roosevelt Pediatric Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
homeopathic ear drops in addition to standard care for otitis media
No ear drops, standard care for otitis
Outcomes
Primary Outcome Measures
Resolution of Otitis Media Symptoms
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
Secondary Outcome Measures
Side Effects of Therapy
Full Information
NCT ID
NCT00622518
First Posted
February 13, 2008
Last Updated
November 4, 2010
Sponsor
University of Washington
Collaborators
Standard Homeopathic Company
1. Study Identification
Unique Protocol Identification Number
NCT00622518
Brief Title
Ear Drops for Children With Otitis Media
Official Title
Ear Drops for Children With Otitis Media
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Standard Homeopathic Company
4. Oversight
Data Monitoring Committee
Yes
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. A total of 120 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
Acute Otitis Media
Keywords
otitis media, children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
homeopathic ear drops in addition to standard care for otitis media
Arm Title
2
Arm Type
No Intervention
Arm Description
No ear drops, standard care for otitis
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
Resolution of Otitis Media Symptoms
Description
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Side Effects of Therapy
Time Frame
5 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:
Presenting to participating clinic with otitis media
Diagnosed with acute otitis media
Parents rate symptoms as a "moderate problem" or more
Exclusion Criteria:
Diagnosis of otitis media within preceding 30 days
Receipt of antibiotics within 2 days
Perforated ear drum or bullous lesion
Receipt of homeopathic treatment within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Taylor
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center-Roosevelt Pediatric Care Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ear Drops for Children With Otitis Media
We'll reach out to this number within 24 hrs