Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
NCT ID: NCT00689468
Last Updated: 2008-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
1999-07-31
2002-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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1
Osteopathic sham treatment plus placebo "Echinacea" drops
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.
"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.
2
Active Echinacea drops plus sham osteopathic treatment
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.
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.
3
Active osteopathic manipulation plus placebo "Echinacea" drops
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).
"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.
4
Active osteopathic manipulation plus active Echinacea drops.
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).
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.
Interventions
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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).
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.
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.
"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.
Eligibility Criteria
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Inclusion Criteria
* 4 episodes of acute otitis media in one year,
Exclusion Criteria
* 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
12 Months
60 Months
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Arizona
OTHER
Responsible Party
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Department of Pediatrics, University of Arizona
Principal Investigators
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Richard A Wahl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Michael B Aldous, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Pediatric Osteopathic Center
Tucson, Arizona, United States
KateCare Osteopathic Center
Tucson, Arizona, United States
Pediatric Clinic, Arizona Health Sciences Center
Tucson, Arizona, United States
Countries
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References
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Mark JD, Grant KL, Barton LL. The use of dietary supplements in pediatrics: a study of echinacea. Clin Pediatr (Phila). 2001 May;40(5):265-9. doi: 10.1177/000992280104000505.
Other Identifiers
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NIH P50 HL61212-01
Identifier Type: -
Identifier Source: secondary_id
Arizona HSC #98-83
Identifier Type: -
Identifier Source: org_study_id