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Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranial osteopathic manipulative treatment.
Echinacea purpurea
Sham osteopathic manipulative treatment
"Echinacea purpurea" placebo
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Otitis Media focused on measuring Otitis media, Echinacea, Osteopathic Medicine

Eligibility Criteria

12 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pediatric Osteopathic Center
  • KateCare Osteopathic Center
  • Pediatric Clinic, Arizona Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Osteopathic sham treatment plus placebo "Echinacea" drops

Active Echinacea drops plus sham osteopathic treatment

Active osteopathic manipulation plus placebo "Echinacea" drops

Active osteopathic manipulation plus active Echinacea drops.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2008
Last Updated
May 30, 2008
Sponsor
University of Arizona
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00689468
Brief Title
Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
Official Title
Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arizona
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Otitis media, Echinacea, Osteopathic Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Osteopathic sham treatment plus placebo "Echinacea" drops
Arm Title
2
Arm Type
Active Comparator
Arm Description
Active Echinacea drops plus sham osteopathic treatment
Arm Title
3
Arm Type
Active Comparator
Arm Description
Active osteopathic manipulation plus placebo "Echinacea" drops
Arm Title
4
Arm Type
Active Comparator
Arm Description
Active osteopathic manipulation plus active Echinacea drops.
Intervention Type
Procedure
Intervention Name(s)
Cranial osteopathic manipulative treatment.
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Echinacea purpurea
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham osteopathic manipulative treatment
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
"Echinacea purpurea" placebo
Intervention Description
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 Outcome Measure Information:
Title
The occurrence of a first episode of acute otitis media during the study period.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
The total number of episodes of diagnosed acute otitis media during the study period.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Wahl, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael B Aldous, MD, MPH
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Osteopathic Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
KateCare Osteopathic Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Pediatric Clinic, Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11388676
Citation
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.
Results Reference
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Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

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