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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00010465 |
Purpose
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 | Intervention | Phase |
|
Otitis Media |
Procedure: Craniosacral Osteopathic Manipulative Treatment Drug: Botanicals |
Phase II |
| MedlinePlus related topics: | Ear Infections |
| ChemIDplus related topics: | Coneflower extract |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children |
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.
Eligibility
| Ages Eligible for Study: | 12 Months to 60 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | P50 AT000008-01P1, 1 P50 AT000008-01 |
| First Received: | February 2, 2001 |
| Last Updated: | August 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00010465 |
| Health Authority: | United States: Federal Government |
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