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NCT00010465 Clinical Trial

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

Otitis Media Clinical Trial

Official title:
Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00010465
Other study ID # P50 AT000008-01P1
Secondary ID 1 P50 AT000008-0
Status Completed
Phase Phase 2
First received February 2, 2001
Last updated March 21, 2013
Est. completion date December 2002

Study information
Verified date March 2013
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).

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.

Other known NCT identifiers
  • NCT00009269

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 60 Months
Eligibility Inclusion Criteria:

- Written informed consent

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Craniosacral Osteopathic Manipulative Treatment

Drug:
• Botanicals

Locations
Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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