A Phase 4 interventional study of Homeopathic medication Plumbum metallicum and Hydroalcoholic solution in Lead Poisoning, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-03.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
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.
27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.
This study's enrollment of 113 is below the median of 175 across 11 interventional studies indexed under Lead Poisoning.
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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.
Drug: Homeopathic medication Plumbum metallicum
The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.
Other: Hydroalcoholic solution
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.
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.
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.
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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