Homeopathic Preparation Plumbum Metallicum for Lead Poisoning - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lead Poisoning	Drug: Homeopathic medication Plumbum metallicum Other: Hydroalcoholic solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effectiveness of the Homeopathic Preparation Plumbum Metallicum in Decreasing Blood Levels in Exposed Workers.

Resource links provided by NLM:

MedlinePlus related topics: Lead Poisoning Poisoning

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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. [ Designated as safety issue: No ]

Estimated Enrollment:

113

Arms	Assigned Interventions
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.	Drug: 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.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.
Placebo Comparator: hydroalcoholic solution The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.	Other: Hydroalcoholic solution 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.

Arms

Assigned Interventions

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.

Drug: 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.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.

Placebo Comparator: hydroalcoholic solution

The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.

Other: Hydroalcoholic solution

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931905

Locations

Brazil
Universidade Federal de Sao Paulo
Sao Paulo, Brazil, 04039-001

Sponsors and Collaborators

Federal University of São Paulo

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00931905 History of Changes
Other Study ID Numbers:	0632/02
Study First Received:	June 30, 2009
Last Updated:	July 31, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

This study included workers exposed to lead.

Additional relevant MeSH terms:

Lead Poisoning
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 18, 2013