Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 31, 1999

Primary Completion Date

September 30, 2002

Study Completion Date

October 31, 2002

Conditions
Otitis Media
Interventions
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.

Trial Locations (3)

85712

Pediatric Osteopathic Center, Tucson

85719

KateCare Osteopathic Center, Tucson

85724-5073

Pediatric Clinic, Arizona Health Sciences Center, Tucson

All Listed Sponsors
collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

lead

University of Arizona

OTHER

NCT00689468 - Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media | Biotech Hunter | Biotech Hunter