- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00931905
Homeopathic Preparation Plumbum Metallicum for Lead Poisoning
July 31, 2009 updated by: Federal University of São Paulo
Effectiveness of the Homeopathic Preparation Plumbum Metallicum in Decreasing Blood Levels in Exposed Workers.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
113
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 04039-001
- Universidade Federal de Sao Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- where in good medical condition, as analyzed by their medical records and physical exam;
- had an initial blood lead level less than the maximum biological concentration permitted, which is 60µ/dL in Brazil.
Exclusion Criteria:
- 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;
- workers who had the right to vacation during the study period;
- workers who did not give their consent to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Homeopathic medication Plumbum metallicum
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.
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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.
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Placebo Comparator: hydroalcoholic solution
The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberto Q Padilha, MD, Federal University of São Paulo
- Study Chair: Rachel Riera, MD, Federal University of São Paulo
- Study Director: Alvaro N Atallah, phD, Federal University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 30, 2009
First Submitted That Met QC Criteria
June 30, 2009
First Posted (Estimate)
July 2, 2009
Study Record Updates
Last Update Posted (Estimate)
August 3, 2009
Last Update Submitted That Met QC Criteria
July 31, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0632/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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