NCT00689468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

3.2 years

First QC Date

May 30, 2008

Last Update Submit

May 30, 2008

Conditions

Otitis Media

Keywords

Otitis mediaEchinaceaOsteopathic Medicine

Outcome Measures

Primary Outcomes (1)

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

    Six months

Secondary Outcomes (1)

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

    Six months

Study Arms (4)

1

PLACEBO COMPARATOR

Osteopathic sham treatment plus placebo "Echinacea" drops

Procedure: Sham osteopathic manipulative treatmentDietary Supplement: "Echinacea purpurea" placebo

2

ACTIVE COMPARATOR

Active Echinacea drops plus sham osteopathic treatment

Dietary Supplement: Echinacea purpureaProcedure: Sham osteopathic manipulative treatment

3

ACTIVE COMPARATOR

Active osteopathic manipulation plus placebo "Echinacea" drops

Procedure: Cranial osteopathic manipulative treatment.Dietary Supplement: "Echinacea purpurea" placebo

4

ACTIVE COMPARATOR

Active osteopathic manipulation plus active Echinacea drops.

Procedure: Cranial osteopathic manipulative treatment.Dietary Supplement: Echinacea purpurea

Interventions

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).

34
Echinacea purpureaDIETARY_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.

24
Sham osteopathic manipulative treatmentPROCEDURE

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.

12
"Echinacea purpurea" placeboDIETARY_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.

13

Eligibility Criteria

Age12 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pediatric Osteopathic Center

Tucson, Arizona, 85712, United States

Location

KateCare Osteopathic Center

Tucson, Arizona, 85719, United States

Location

Pediatric Clinic, Arizona Health Sciences Center

Tucson, Arizona, 85724-5073, United States

Location

Related Publications (1)

  • 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.

    PMID: 11388676BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Richard A Wahl, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

  • Michael B Aldous, MD, MPH

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

July 1, 1999

Primary Completion

September 1, 2002

Study Completion

October 1, 2002

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

US(3)