Otitis MediaNCT01003210
Homeopathic Ear Drops for Otitis Media Study
A study testing Hyland's earache drops in people with Otitis Media, run by University of Washington at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Hyland's earache drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mercer Island Pediatric Associates
Mercer Island, Washington, 98040
Valley Children's Clinic
Renton, Washington, 98055
University of Washington Medical Center-Roosevelt Pediatric Care Center
Seattle, Washington, 98195
About this study
Official title: Homeopathic Ear Drops for Children With Otitis Media Study
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.
- Conditions
- Otitis Media
- Being tested
- Hyland's earache drops
- Keywords
- otitis media, children, homeopathy
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyland's earache dropsDrug
3-4 drops in affected ear 3 times a day as needed for up to 5 days
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic ear drops | Experimental | Commercially available homeopathic ear drops Receives: Drug: Hyland's earache drops |
| standard therapy | No intervention | standard therapy for otitis media, no ear drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 15 days
Secondary outcomes (1)
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Taylor, University of Washington
- Investigators
- James A Taylor, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003210
- Sponsor's protocol ID
- 37011
- Status last verified
- May 2018
- First submitted
- 26 Oct 2009
- Last updated
- 8 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Ear Drops for Children With Otitis Media Study
- ClinicalTrials.gov ID
- NCT01003210
- Acronym / sponsor ID
- 37011
- Conditions
- Otitis Media
- Keywords
- otitis media, children, homeopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 22 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathic ear drops | Experimental | Drug: Hyland's earache dropsCommercially available homeopathic ear drops |
| standard therapy | No intervention | –standard therapy for otitis media, no ear drops |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyland's earache drops3-4 drops in affected ear 3 times a day as needed for up to 5 days | Drug | Homeopathic ear drops |
Primary outcome
Severity of Symptoms of Otitis Media
Time frame: 15 days
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
Administration of Antibiotics
Time frame: 15 days
Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
1 secondary outcome
Side Effects From Study Remedy
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Otitis Media
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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
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Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Taylor, MD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyland's earache drops in people with Otitis Media, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Symptoms of Otitis Media (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.