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| ID | Type | Description | Link |
|---|---|---|---|
| 07-9092-B 01 |
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| Name | Class |
|---|---|
| Standard Homeopathic Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | homeopathic ear drops in addition to standard care for otitis media |
|
| 2 | No Intervention | No ear drops, standard care for otitis |
| 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 |
|---|---|---|
| Resolution of Otitis Media Symptoms | Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects of Therapy | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Taylor | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center-Roosevelt Pediatric Care Center | Seattle | Washington | 98105 | United States |
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patients were recruited from 2/4/08 through 2/23/09 at a pediatric primary care clinic at the time of a visit for acute otitis media
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| ID | Title | Description |
|---|---|---|
| FG000 | Ear Drops Plus Standard Therapy | homeopathic ear drops in addition to standard care for otitis media |
| FG001 | Standard Therapy Alone | No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ear Drops Plus Standard Therapy | homeopathic ear drops in addition to standard care for otitis media |
| BG001 | Standard Therapy Alone | No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen |
| 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 | Resolution of Otitis Media Symptoms | Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day. | Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED | Posted | Mean | Standard Deviation | units on a scale | 5 days |
|
2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ear Drops Plus Standard Therapy | homeopathic ear drops in addition to standard care for otitis media |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A. Taylor, MD | University of Washington | 206-616-1206 | uncjat@u.washington.edu |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Ear Drops Plus Standard Therapy |
homeopathic ear drops in addition to standard care for otitis media |
| OG001 | Standard Therapy Alone | No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen |
|
|
|
| Secondary | Side Effects of Therapy | Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects. | Posted | Number | participants | 5 days |
|
|
|
| 0 |
| 59 |
| 29 |
| 44 |
| EG001 | Standard Therapy Alone | No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen | 0 | 60 | 37 | 50 |
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| "hyper" behavior | General disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| lethargy | General disorders | Systematic Assessment |
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| other | General disorders | Systematic Assessment |
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| rash reported at least once in diary |
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| diarrhea reported at least once in diary |
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| "hyper" behavior reported at least once in diary |
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| headache reported at least once in diary |
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| lethargy reported at least once in diary |
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| other symptom reported at least once in diary |
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| serious side effect reported |
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