The aim of the study is to investigate the therapeutic effects of garlic in alleviation of clinical symptoms of mild to moderate occupational lead poisoning and its effect in reducing blood lead levels. Clinical data of possible lead poisoning from more than 100 workers employed in a car battery industry will be obtained. The patients' blood and urine lead levels are measured and then workers with 200-500 μg/L lead levels who have worked for more than a year in the companies will be included in the study and randomly divided into two groups. The first group will be treated by Penicillamine 1000 mgs daily for 4 weeks and the second group will be treated by garlic 1600 mgs daily within the same period. After the one-month treatment, lead serum level will be measured and clinical and laboratory tests will be repeated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804062083N1
Registration date:2010-06-19, 1389/03/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-19, 1389/03/29
Registrant information
Name
Seyed Reza Mousavi
Name of organization / entity
Imam Reza Hospital, Mashhad University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8973
Email address
mousavir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2010-06-21, 1389/03/31
Expected recruitment end date
2010-07-22, 1389/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of therapeutic effects of garlic and penicillamine in patients with chronic occupational lead poisoning
Public title
A comparative study of therapeutic effects of garlic and penicillamine in patients with chronic occupational lead poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: employees who has worked more than one year in a car battery industry, blood lead levels of 200-500 μg/L
Exclusion criteria: family history of allergy to penicillin and drugs that have cross-sensitivity to penicillin, antimalarial drugs and gold salt, history of agranolocytosis or anemia in previous use of penicillamine, known heart, liver or renal failure, hypersensitivity to garlic, hemorrhagic diathesis, elective surgery during and 10 days after the consumption of garlic, using antibiotics or anticoagulant drugs
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Department, Mashad University of Medical Sciences
Street address
2nd floor - (Central Department of Mashad University of Medical Sciences (Ghoreyshi building) - Daneshgah avenue
City
Mashad
Postal code
Approval date
2009-04-11, 1388/01/22
Ethics committee reference number
87855
Health conditions studied
1
Description of health condition studied
Lead poisoning
ICD-10 code
T56.0
ICD-10 code description
Toxic effects of lead and its compounds
Primary outcomes
1
Description
blood lead levels
Timepoint
Baseline and 1 month after the intervention
Method of measurement
by atomic absorption device, model Perkin Elmer 3030, through the technique of Heated Graphite Atomization
2
Description
signs and symptoms
Timepoint
Baseline and 1 month after the intervention
Method of measurement
medical examination
Secondary outcomes
1
Description
side effects
Timepoint
routine medical examination to find possible abnormal signs and symptoms - Complete blood count 15 days after the initiation of intervention
Method of measurement
Routine medical examination - Complete blood count 15 days after the initation of treatment
2
Description
blood sugar
Timepoint
Baseline and 1 month after the intervention
Method of measurement
laboratory testing
3
Description
Liid profile invluding (cholestrol, triglyceride, HDL and LDL)
Timepoint
Baseline and one month after the intervention
Method of measurement
laboratory testing
Intervention groups
1
Description
Penicillamine Cap 250 mg 4 times daily for 4 weeks
Category
Treatment - Drugs
2
Description
Garlic Tab 400 mg 4 times daily for 4 weeks (each tablet contains 1200 microgram allicin)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Niroogostaran battery-making company
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Afzal Aghayi
Street address
Research Department (Ghoreyshi building) - 2nd floor - Daneshgah Avenue
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical Toxicology Center
Full name of responsible person
Dr. Mahdi Balali Mood
Position
MD - Ph.D. in Clinical Pharmacology and Toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital - Medical Toxicology Center
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
Email
mbalalimood@hotmail.com ; balalimoodm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Toxicology Center
Full name of responsible person
Dr. Mahdi Balali Mood
Position
MD - Ph.D. in Clinical Pharmacology and Toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital - Medical Toxicology Center
City
Mashhad
Postal code
Phone
+98 51 1859 8973
Fax
Email
mbalalimood@hotmail.com ; balalimoodm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Sina Kianoush
Position
Medical student
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)