NCT01003210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 22, 2014

Completed
Last Updated

June 8, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

October 26, 2009

Results QC Date

May 19, 2014

Last Update Submit

May 8, 2018

Conditions

Otitis Media

Keywords

otitis mediachildrenhomeopathy

Outcome Measures

Primary Outcomes (2)

  • 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

    15 days

  • 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.

    15 days

Secondary Outcomes (1)

  • Side Effects From Study Remedy

    15 days

Study Arms (2)

Homeopathic ear drops

EXPERIMENTAL

Commercially available homeopathic ear drops

Drug: Hyland's earache drops

standard therapy

NO INTERVENTION

standard therapy for otitis media, no ear drops

Interventions

Hyland's earache dropsDRUG

3-4 drops in affected ear 3 times a day as needed for up to 5 days

Homeopathic ear drops

Eligibility Criteria

Age6 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mercer Island Pediatric Associates

Mercer Island, Washington, 98040, United States

Location

Valley Children's Clinic

Renton, Washington, 98055, United States

Location

University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Limitations and Caveats

Initially planned sample size --150. Study size was increased after analysis of initial data found a non-significant trend between antibiotic fill rates in the homeopathic ear drop and standard therapy treatment groups.

Results Point of Contact

Title
Dr. James Taylor
Organization
University of Washington
uncjat@uw.edu
206-6165-1206

Study Officials

  • James A Taylor, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2013

Study Completion

December 1, 2013

Last Updated

June 8, 2018

Results First Posted

July 22, 2014

Record last verified: 2018-05

Locations

US(3)