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Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

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ClinicalTrials.gov Identifier: NCT00010465
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : March 22, 2013
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).

Condition or disease Intervention/treatment Phase
Otitis Media Procedure: Craniosacral Osteopathic Manipulative Treatment Drug: Botanicals Phase 2

Detailed Description:
Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010465


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724-5073
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Michael Aldous University of Arizona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00010465    
Obsolete Identifiers: NCT00009269
Other Study ID Numbers: P50AT000008-01P1 ( U.S. NIH Grant/Contract )
1P50AT000008-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases