Skip to main content
OpenTrials
Completed

NCT Number: NCT00689468

Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

12 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KateCare Osteopathic Center, Tucson, Arizona, United States

Loading trial locations.

About this study

The use of complementary and alternative therapies by parents of young children remains common despite the lack of clinical trials demonstrating either the efficacy or safety of these treatments. Two of the more common complementary therapies used in young children with a history of recurrent otitis media are preparations of the herb Echinacea purpurea and cranial osteopathic manipulative treatment. This study represents one of the first double-blinded, placebo controlled trials of each approach in a population of young children who presented with three or more recent episodes of acute otitis media.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 3 or more separate episodes of acute otitis media within a 6 month period, or
  • 4 episodes of acute otitis media in one year,

Exclusion criteria

  • Congenital malformations of the ears, nose, or throat
  • Known or suspected allergy to echinacea
  • Immune deficiency including HIV infection
  • Tuberculosis
  • Current use of prophylactic antibiotics
  • Tympanostomy tubes in place
  • Unwillingness of child to participate

Treatment and study plan

Cranial osteopathic manipulative treatment.

Procedure

A series of five cranial osteopathic manipulative treatment sessions scheduled over three months, and provided by osteopathic physicians whose practices are limited to osteopathic manipulative treatment. Treatment modalities were limited to cranial osteopathy, balanced membranous/ligamentous tension, and/or myofascial release (applied directly or indirectly).

Echinacea purpurea

Dietary Supplement

1:1 weight-to-volume 50% ethanol liquid extract of the fresh roots and dried mature seeds of Echinacea purpurea. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.

Sham osteopathic manipulative treatment

Procedure

Sham osteopathic treatment consisted of a series of five osteopathic examinations only (palpation of the cranial bones and muscles and other structures) without treatment maneuvers.

"Echinacea purpurea" placebo

Dietary Supplement

An identically labeled placebo contained 50% ethanol, 45% filtered water, food coloring and thickeners. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.

Primary outcomes

  1. The occurrence of a first episode of acute otitis media during the study period.

    Time frame: Six months

Secondary outcomes

  1. The total number of episodes of diagnosed acute otitis media during the study period.

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Jun 3, 2008
Registry last updated
Jun 3, 2008

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.