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

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

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

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).

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 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

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Written informed consent

Gender

Both

Ages

12 Months to 60 Months

Accepts Healthy Volunteers

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)

Collaborators ^††

Investigators ^†

Principal Investigator:

Michael Aldous

University of Arizona

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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.