Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-28 @ 11:31 PM
Study NCT ID:
NCT00689468
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2008-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718679', 'term': 'Echinacea extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-30', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of a first episode of acute otitis media during the study period.', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'The total number of episodes of diagnosed acute otitis media during the study period.', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Otitis media', 'Echinacea', 'Osteopathic Medicine'], 'conditions': ['Otitis Media']}, 'referencesModule': {'references': [{'pmid': '11388676', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 or more separate episodes of acute otitis media within a 6 month period, or\n* 4 episodes of acute otitis media in one year,\n\nExclusion Criteria:\n\n* Congenital malformations of the ears, nose, or throat\n* Known or suspected allergy to echinacea\n* Immune deficiency including HIV infection\n* Tuberculosis\n* Current use of prophylactic antibiotics\n* Tympanostomy tubes in place\n* Unwillingness of child to participate'}, 'identificationModule': {'nctId': 'NCT00689468', 'briefTitle': 'Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Arizona HSC #98-83'}, 'secondaryIdInfos': [{'id': 'NIH P50 HL61212-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Osteopathic sham treatment plus placebo "Echinacea" drops', 'interventionNames': ['Procedure: Sham osteopathic manipulative treatment', 'Dietary Supplement: "Echinacea purpurea" placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Active Echinacea drops plus sham osteopathic treatment', 'interventionNames': ['Dietary Supplement: Echinacea purpurea', 'Procedure: Sham osteopathic manipulative treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Active osteopathic manipulation plus placebo "Echinacea" drops', 'interventionNames': ['Procedure: Cranial osteopathic manipulative treatment.', 'Dietary Supplement: "Echinacea purpurea" placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Active osteopathic manipulation plus active Echinacea drops.', 'interventionNames': ['Procedure: Cranial osteopathic manipulative treatment.', 'Dietary Supplement: Echinacea purpurea']}], 'interventions': [{'name': 'Cranial osteopathic manipulative treatment.', 'type': 'PROCEDURE', '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).', 'armGroupLabels': ['3', '4']}, {'name': 'Echinacea purpurea', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['2', '4']}, {'name': 'Sham osteopathic manipulative treatment', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['1', '2']}, {'name': '"Echinacea purpurea" placebo', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pediatric Osteopathic Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'KateCare Osteopathic Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724-5073', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pediatric Clinic, Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Richard A Wahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}, {'name': 'Michael B Aldous, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Richard Wahl, MD', 'oldOrganization': 'Department of Pediatrics, University of Arizona'}}}}