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Homeopathic Preparation Plumbum Metallicum for Lead Poisoning

Primary Purpose

Lead Poisoning

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Homeopathic medication Plumbum metallicum
Hydroalcoholic solution
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lead Poisoning focused on measuring This study included workers exposed to lead.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Homeopathic medication Plumbum metallicum

hydroalcoholic solution

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2009
Last Updated
July 31, 2009
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00931905
Brief Title
Homeopathic Preparation Plumbum Metallicum for Lead Poisoning
Official Title
Effectiveness of the Homeopathic Preparation Plumbum Metallicum in Decreasing Blood Levels in Exposed Workers.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lead Poisoning
Keywords
This study included workers exposed to lead.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (false)

8. Arms, Groups, and Interventions

Arm Title
Homeopathic medication Plumbum metallicum
Arm Type
Experimental
Arm 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.
Arm Title
hydroalcoholic solution
Arm Type
Placebo Comparator
Arm Description
The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol.
Intervention Type
Drug
Intervention Name(s)
Homeopathic medication Plumbum metallicum
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Hydroalcoholic solution
Intervention 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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Q Padilha, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Riera, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alvaro N Atallah, phD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04039-001
Country
Brazil

12. IPD Sharing Statement

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Homeopathic Preparation Plumbum Metallicum for Lead Poisoning

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