Otitis MediaNCT00689468
Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
A study testing Cranial osteopathic manipulative treatment. and Echinacea purpurea in people with Otitis Media, run by University of Arizona at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media
- What is being tested?
- Cranial osteopathic manipulative treatment. and Echinacea purpurea
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 1999to Oct 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 or more separate episodes of acute otitis media within a 6 month period, or
- 4 episodes of acute otitis media in one year,
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pediatric Osteopathic Center
Tucson, Arizona, 85712
KateCare Osteopathic Center
Tucson, Arizona, 85719
Pediatric Clinic, Arizona Health Sciences Center
Tucson, Arizona, 85724-5073
About this study
Official title: Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.
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.
Read the 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
- Being tested
- Cranial osteopathic manipulative treatment., Echinacea purpurea, Sham osteopathic manipulative treatment, "Echinacea purpurea" placebo
- Keywords
- Otitis media, Echinacea, Osteopathic Medicine
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial osteopathic manipulative treatment.Procedure or surgery
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 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.
Sham osteopathic manipulative treatmentProcedure or surgery
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" 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Osteopathic sham treatment plus placebo "Echinacea" drops Receives: Procedure: Sham osteopathic manipulative treatment; Dietary Supplement: "Echinacea purpurea" placebo |
| 2 | Active comparator | Active Echinacea drops plus sham osteopathic treatment Receives: Dietary Supplement: Echinacea purpurea; Procedure: Sham osteopathic manipulative treatment |
| 3 | Active comparator | Active osteopathic manipulation plus placebo "Echinacea" drops Receives: Procedure: Cranial osteopathic manipulative treatment.; Dietary Supplement: "Echinacea purpurea" placebo |
| 4 | Active comparator | Active osteopathic manipulation plus active Echinacea drops. Receives: Procedure: Cranial osteopathic manipulative treatment.; Dietary Supplement: Echinacea purpurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of a first episode of acute otitis media during the study period.
Measured: Six months
Secondary outcomes (1)
The total number of episodes of diagnosed acute otitis media during the study period.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 1999
- Primary completionSep 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Richard A Wahl, MD, Principal investigator, University of ArizonaMichael B Aldous, MD, MPH, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689468
- Sponsor's protocol ID
- Arizona HSC #98-83
- Other IDs
- NIH P50 HL61212-01
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11388676
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00689468
- Acronym / sponsor ID
- Arizona HSC #98-83
- Conditions
- Otitis Media
- Keywords
- Otitis media, Echinacea, Osteopathic Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 1999
- Primary completion
- Sep 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Sham osteopathic manipulative treatment, Dietary Supplement: "Echinacea purpurea" placeboOsteopathic sham treatment plus placebo "Echinacea" drops |
| 2 | Active comparator | Dietary Supplement: Echinacea purpurea, Procedure: Sham osteopathic manipulative treatmentActive Echinacea drops plus sham osteopathic treatment |
| 3 | Active comparator | Procedure: Cranial osteopathic manipulative treatment., Dietary Supplement: "Echinacea purpurea" placeboActive osteopathic manipulation plus placebo "Echinacea" drops |
| 4 | Active comparator | Procedure: Cranial osteopathic manipulative treatment., Dietary Supplement: Echinacea purpureaActive osteopathic manipulation plus active Echinacea drops. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3 or more separate episodes of acute otitis media within a 6 month period, or
- 4 episodes of acute otitis media in one year,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | 3, 4 |
| Echinacea purpurea1:1 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. | Dietary supplement | 2, 4 |
| Sham osteopathic manipulative treatmentSham osteopathic treatment consisted of a series of five osteopathic examinations only (palpation of the cranial bones and muscles and other structures) without treatment maneuvers. | Procedure or surgery | 1, 2 |
| "Echinacea purpurea" placeboAn 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. | Dietary supplement | 1, 3 |
Primary outcome
The occurrence of a first episode of acute otitis media during the study period.
Time frame: Six months
1 secondary outcome
The total number of episodes of diagnosed acute otitis media during the study period.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
- Background: PubMed 11388676Mark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Wahl, MD principal investigator
University of Arizona
Michael B Aldous, MD, MPH principal investigator
University of Arizona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial osteopathic manipulative treatment. and Echinacea purpurea in people with Otitis Media, run by University of Arizona at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of a first episode of acute otitis media during the study period. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00689468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2008.