Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homeopathic ear drops | Experimental | Commercially available homeopathic ear drops |
|
| standard therapy | No Intervention | standard therapy for otitis media, no ear drops |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyland's earache drops | Drug | 3-4 drops in affected ear 3 times a day as needed for up to 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James A Taylor, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercer Island Pediatric Associates | Mercer Island | Washington | 98040 | United States | ||
| Valley Children's Clinic |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Homeopathic Ear Drops | Commercially available homeopathic ear drops Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days |
| FG001 | Standard Therapy | standard therapy for otitis media, no ear drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children 6 months - 11 years old diagnosed with acute otitis media and managed with a delayed antibiotic treatment approach
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Homeopathic Ear Drops | Commercially available homeopathic ear drops Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days |
| BG001 | Standard Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 15 days |
|
Not provided
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Homeopathic Ear Drops | Commercially available homeopathic ear drops Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomit | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Taylor | University of Washington | 206-6165-1206 | uncjat@uw.edu |
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Renton |
| Washington |
| 98055 |
| United States |
| University of Washington Medical Center-Roosevelt Pediatric Care Center | Seattle | Washington | 98195 | United States |
standard therapy for otitis media, no ear drops
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | participants | 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. | The number of participants analyzed includes only those whose parents returned logbooks. | Posted | Number | participants | 15 days |
|
|
|
| 0 |
| 104 |
| 58 |
| 104 |
| EG001 | Standard Therapy | standard therapy for otitis media, no ear drops | 0 | 102 | 88 | 102 |
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| "hyper" behavior | Psychiatric disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| lethargy | General disorders | Systematic Assessment |
|
| Others | General disorders | Systematic Assessment |
|
| decreased hearing | Ear and labyrinth disorders | Systematic Assessment |
|
| ear plugging | Ear and labyrinth disorders | Systematic Assessment |
|
| ears popping | Ear and labyrinth disorders | Systematic Assessment |
|
| redness around ear | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| diarrhea |
|
| "hyper" behavior |
|
| headache |
|
| lethargy |
|
| other symptom reported |
|
| decreased hearing |
|
| "plugged" ears |
|
| redness around ear with drops |
|
| ear popping |
|