An interventional study of Hyland's earache drops in Acute Otitis Media, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 6 Months to 11 Years. Per ClinicalTrials.gov, last updated 2010-12-02.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
246 studies on the registry are indexed under Otitis; 21 are open to participants now.
This study's enrollment of 119 is close to the median of 126 across 173 interventional studies indexed under Otitis.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
homeopathic ear drops in addition to standard care for otitis media
Drug: Hyland's earache drops
No ear drops, standard care for otitis
3-4 drops in affected ear 3 times a day as needed for up to 5 days
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.
Time frame: 5 days
Side Effects of Therapy
Time frame: 5 days
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
| Milestone | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|
| Started | 59 | 60 |
| Completed | 59 | 60 |
| Not completed | 0 | 0 |
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.
| units on a scale | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|
| Assessment 1: day 1, am | 14.2 ± 8.2 | 16.5 ± 8.2 |
| Assessment 2: day 1, pm | 7.5 ± 10.5 | 14.1 ± 7.4 |
| Assessment 3: day 2, am | 6.1 ± 6.7 | 10.8 ± 8.1 |
| Assessment 4: day 2, pm | 6.7 ± 6.0 | 8.7 ± 7.8 |
| Assessment 5: day 3, am | 6.1 ± 6.6 | 7.0 ± 8.3 |
| Assessment 6: day 3, pm | 5.2 ± 6.3 | 7.3 ± 8.7 |
| Assessment 7: day 4, am | 3.8 ± 6.1 | 5.8 ± 7.8 |
| Assessment 8: day 4, pm | 3.3 ± 5.1 | 3.7 ± 5.7 |
| Assessment 9: day 5, am | 2.8 ± 5.7 | 3.7 ± 5.7 |
| Assessment 10: day 5, pm | 2.3 ± 4.1 | 3.4 ± 5.7 |
| participants | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|
| Any side effect reported in diary | 29 | 37 |
| vomiting reported at least once in diary | 5 | 10 |
| rash reported at least once in diary | 3 | 5 |
| diarrhea reported at least once in diary | 3 | 12 |
| "hyper" behavior reported at least once in diary | 3 | 11 |
| headache reported at least once in diary | 7 | 6 |
| lethargy reported at least once in diary | 13 | 15 |
| other symptom reported at least once in diary | 19 | 22 |
| serious side effect reported | 0 | 0 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ear Drops Plus Standard Therapy | — | 0/59 (0%) | 29/44 (65.9%) |
| Standard Therapy Alone | — | 0/60 (0%) | 37/50 (74%) |
| Event | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|
| lethargyGeneral disorders | 13/44 | 25/50 |
| otherGeneral disorders | 19/44 | 22/50 |
| diarrheaGastrointestinal disorders | 3/44 | 12/50 |
| "hyper" behaviorGeneral disorders | 3/44 | 11/50 |
| vomitingGastrointestinal disorders | 5/44 | 10/50 |
| headacheGeneral disorders | 7/44 | 6/50 |
| rashSkin and subcutaneous tissue disorders | 3/44 | 5/50 |
| Age, Categorical(Participants) | Ear Drops Plus Standard Therapy | Standard Therapy Alone | Total |
|---|---|---|---|
| <=18 years | 59 | 60 | 119 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Ear Drops Plus Standard Therapy | Standard Therapy Alone | Total |
|---|---|---|---|
| Mean | 3.6 ± 2.5 | 3.4 ± 2.4 | 3.5 ± 2.4 |
| Sex: Female, Male(Participants) | Ear Drops Plus Standard Therapy | Standard Therapy Alone | Total |
|---|---|---|---|
| Female | 30 | 25 | 55 |
| Male | 29 | 35 | 64 |
| Region of Enrollment(participants) | Ear Drops Plus Standard Therapy | Standard Therapy Alone | Total |
|---|---|---|---|
| United States | 59 | 60 | 119 |
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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University of Washington