NCT00689468

Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 12 Months – 60 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Otitis Media

Interventions

Type	Name	Description
PROCEDURE	Cranial osteopathic manipulative treatment.	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).
DIETARY_SUPPLEMENT	Echinacea purpurea	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.
PROCEDURE	Sham osteopathic manipulative treatment	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.
DIETARY_SUPPLEMENT	"Echinacea purpurea" placebo	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.

Timeline

• Start date: 1999-07-01
• Primary completion: 2002-09-01
• Completion: 2002-10-01
• First posted: 2008-06-03
• Last updated: 2008-06-03

Locations

3 sites across 1 country: United States