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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01003210
Other study ID # 37011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date December 2013

Study information

Verified date May 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date December 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 6 Months to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyland's earache drops
3-4 drops in affected ear 3 times a day as needed for up to 5 days

Locations

Country Name City State
United States Mercer Island Pediatric Associates Mercer Island Washington
United States Valley Children's Clinic Renton Washington
United States University of Washington Medical Center-Roosevelt Pediatric Care Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 15 days
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