Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT00065702
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Homeopathy in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2002-09'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2003-07-31', 'studyFirstSubmitQcDate': '2003-07-31', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['fibromyalgia', 'homeopathy', 'EEG', 'EKG', 'chronic pain'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of individualized classical homeopathy in treatment of persons with fibromyalgia and to determine the usefulness of electroencephalographic and electrocardiographic measures to serve as markers of differences between active and placebo treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* ACR diagnosis of fibromyalgia;\n* Willing to take daily active or placebo liquid remedy under double blind conditions for 6 months, involving daily succussion and dilution of source liquid from a stock bottle;\n* Willingness/ability to comply with dietary and lifestyle restrictions, i.e., no coffee in any form, no comphor or menthol-containing products; no electric blankets, no strong aromatics, no routine vaccinations, no concomitant use of acupuncture, chiropractic, polarity therapy, psychic healing, or magnet therapy;\n* No dental drilling, MRI scans unless emergent;\n* Withhold food or drink 30 mins before/after therapy;\n* Stable conventional care for 2 months prior to entry;\n* Willing to undergo 3 diagnostic physical exams, and to permit videotaping of interview sessions;\n* Willing to fill out questionnaires\n\nExclusion criteria:\n\n* Steroid-dependent medical conditions;\n* Chronic benzodiazepine or anticonvulsant use;\n* Use of tricyclic antidepressants, antihypertensives, and other drugs that alter orthostasis;\n* Pregnancy;\n* History of seizure disorder or syncope;\n* Life-threatening medical conditions;\n* Current active asthma;\n* History of anaphylactic shock;\n* Insulin-dependent diabetes;\n* Active suicidal ideation or psychosis.'}, 'identificationModule': {'nctId': 'NCT00065702', 'briefTitle': 'Biomarkers of Homeopathy in Fibromyalgia', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'orgStudyIdInfo': {'id': 'R21AT000315-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT000315-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'BellI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Active liquid remedy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'U of Arizona College of Medicine, Program in Integrative Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Iris R. Bell, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}