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Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
This study has been completed.
Study NCT00010465   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 2, 2001   Last Updated: August 16, 2006   History of Changes

February 2, 2001
August 16, 2006
 
 
 
 
Complete list of historical versions of study NCT00010465 on ClinicalTrials.gov Archive Site
 
 
 
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children

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).

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.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Otitis Media
  • Procedure: Craniosacral Osteopathic Manipulative Treatment
  • Drug: Botanicals
 
Wahl RA, Aldous MB, Worden KA, Grant KL. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial. BMC Complement Altern Med. 2008 Oct 2;8:56.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Inclusion Criteria:

  • Written informed consent
Both
12 Months to 60 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010465
 
P50 AT000008-01P1, 1 P50 AT000008-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Michael Aldous University of Arizona
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP