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Completed

NCT Number: NCT00010465

Nervous System Manipulation and Botanicals 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).

Completed

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Key information

Age range

12 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arizona

Tucson, Arizona, 85724-5073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent

Treatment and study plan

Craniosacral Osteopathic Manipulative Treatment

Procedure

Botanicals

Drug

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

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

Important dates

Primary completion
2002
Study completion
2002
First posted
Feb 5, 2001
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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