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| Descriptive Information Fields | |||||
| Brief Title † | Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children | ||||
| Official Title † | Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children | ||||
| 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). |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Otitis Media | ||||
| Intervention † | Procedure: Craniosacral Osteopathic Manipulative Treatment Drug: Botanicals |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
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| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Months to 60 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00010465 | ||||
| Organization ID | P50 AT000008-01P1 | ||||
| Secondary IDs †† | 1 P50 AT000008-01 | ||||
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
| First Received Date † | February 2, 2001 | ||||
| Last Updated Date | August 16, 2006 | ||||