Homeopathic Ear Drops for Otitis Media Study

Otitis Media Clinical Trial

Official title:

Homeopathic Ear Drops for Children With Otitis Media Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003210
• Other study ID #: 37011
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Otitis
• Otitis Media

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