Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00931905
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2009-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Homeopathic Preparation Plumbum Metallicum for Lead Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007855', 'term': 'Lead Poisoning'}], 'ancestors': [{'id': 'D000075322', 'term': 'Heavy Metal Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-31', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of the homeopathic preparation Plumbum metallicum in treating poisoning with respect to the decrease of the blood lead level of workers exposed to lead.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['This study included workers exposed to lead.'], 'conditions': ['Lead Poisoning']}, 'descriptionModule': {'briefSummary': 'Saturnism, or lead poisoning, is defined by clinical symptoms (affecting primarily the nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and reproductive systems) compatible with exposure, in the short or long term, to lead or to its compounds, and can manifest as acute or chronic symptoms, pursuant to the intensity and duration of the signs and symptoms. Measuring serum concentration is the primary method for diagnosing and accompanying exposed workers. Presently, elevated lead counts are reversed by using drugs whose effectiveness is contested on various fronts. Experimental studies shows the efficacy of homeopathic preparations in controlling blood lead levels in laboratory animals, creating the need for controlled studies that evaluate the effectiveness and safety of these preparations in humans.The objective of this study was evaluate the effectiveness of the homeopathic preparation Plumbum metallicum in reducing the blood lead level of workers exposed to this metal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had not taken a leave of absence for any reason for a period greater than seven days in the 60 days prior to the intervention;\n* where in good medical condition, as analyzed by their medical records and physical exam;\n* had an initial blood lead level less than the maximum biological concentration permitted, which is 60µ/dL in Brazil.\n\nExclusion Criteria:\n\n* workers who, in the last six months, had used medication that interferes/d with the level of lead in the blood, such as EDTA, BAL, penicillinase and DMSA;\n* workers who had the right to vacation during the study period;\n* workers who did not give their consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT00931905', 'briefTitle': 'Homeopathic Preparation Plumbum Metallicum for Lead Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of the Homeopathic Preparation Plumbum Metallicum in Decreasing Blood Levels in Exposed Workers.', 'orgStudyIdInfo': {'id': '0632/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homeopathic medication Plumbum metallicum', 'description': 'The homeopathic medication Plumbum metallicum 15CH was used, and was diluted and dynamized using the Hahnemann centesimal scale, whose matrix was obtained from the Schraiber laboratory in 4CH in 70% ethanol. From this solution, the matrix was elevated to 14CH in 70% ethanol. The 15CH dynamization was prepared in 30% ethanol, which was the recommended solution for administration.', 'interventionNames': ['Drug: Homeopathic medication Plumbum metallicum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'hydroalcoholic solution', 'description': 'The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.', 'interventionNames': ['Other: Hydroalcoholic solution']}], 'interventions': [{'name': 'Homeopathic medication Plumbum metallicum', 'type': 'DRUG', 'description': 'The homeopathic medication Plumbum metallicum 15CH was used and was diluted and dynamized using the Hahnemann centesimal scale, whose matrix was obtained from the Schraiber laboratory in 4CH in 70% ethanol. From this solution, the matrix was elevated to 14CH in 70% ethanol. The 15CH dynamization was prepared in 30% ethanol, which was the recommended solution for administration.The drugs were administered orally (ten drops) twice daily - at the beginning and the end of the shift and under supervision for 30 days. The patients were instructed not to take other medication without medical guidance during the time they were participating in the research.', 'armGroupLabels': ['Homeopathic medication Plumbum metallicum']}, {'name': 'Hydroalcoholic solution', 'type': 'OTHER', 'description': 'The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol. It was administered orally (ten drops) twice daily - at the beginning and the end of the shift and under supervision for 30 days. The patients were instructed not to take other medication without medical guidance during the time they were participating in the research.', 'armGroupLabels': ['hydroalcoholic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04039-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Roberto Q Padilha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Rachel Riera, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Alvaro N Atallah, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}}}}