Homeopathic Preparation Plumbum Metallicum for Lead Poisoning

NCT ID: NCT00931905

Last Updated: 2009-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

Lead Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Homeopathic medication Plumbum metallicum

Intervention Type: DRUG

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.

hydroalcoholic solution

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

Group Type: PLACEBO_COMPARATOR

Hydroalcoholic solution

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Principal Investigators

Roberto Q Padilha, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Rachel Riera, MD

Role: STUDY_CHAIR

Federal University of São Paulo

Alvaro N Atallah, phD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

0632/02

Identifier Type: -

Identifier Source: org_study_id