Ear Drops for Children With Otitis Media

NCT ID: NCT00622518

Last Updated: 2010-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Otitis Media

Keywords

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otitis media children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

homeopathic ear drops in addition to standard care for otitis media

Group Type ACTIVE_COMPARATOR

Hyland's earache drops

Intervention Type DRUG

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

2

No ear drops, standard care for otitis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyland's earache drops

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Standard Homeopathic Company

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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James A Taylor

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Medical Center-Roosevelt Pediatric Care Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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07-9092-B 01

Identifier Type: -

Identifier Source: secondary_id

33097-B

Identifier Type: -

Identifier Source: org_study_id