Study of the efficacy of adding garlic to standard treatment for lead poisoning
Design
This is a controlled double-blinded clinical trial. This study will be conducted on 160 individuals with lead poisoning. After coordination and obtaining informed consent, clinical examinations and blood lead concentration of all patients will be investigated. The patients (n=80 per group) will be randomly assigned into two groups of standard treatment (penicillamine) and placebo or standard treatment and garlic (4 cubes of garlic and penicillamine tablets containing the usual dose of this drug) and will be treated for 4 weeks and taking drug 3 three times daily. Lead concentration will be determined again 10 days post-treatment.
Settings and conduct
This study will be conducted on 160 individuals with lead poisoning referred to lead clinic of Razi hospital in Ahvaz. The patients will be randomly assigned into two groups of standard treatment and placebo or standard treatment and garlic and will be treated for 4 weeks. Pharmacological intervention (either garlic or placebo) and patient evaluation will be carried out by a physician who will be blinded to treatment groups. Also statistical analyzer will not know about patient grouping (double-blinded study)
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, New lead poisoning, Consent to participate in the study; Exclusion criteria: presence of serious side effects such as the complications requiring dialysis or seizure, Failure to receive treatment for any reason.
Intervention groups
Control: standard treatment (penicillamine) and placebo.
Intervention: standard treatment and garlic (4 cubes of garlic and penicillamine tablets containing the usual dose of this drug).
Main outcome variables
Reduction of Lead concentration; Symptoms of lead poisoning (hematologic and neurological symptoms); Duration of symptoms reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041552N1
Registration date:2018-12-01, 1397/09/10
Registration timing:registered_while_recruiting
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Seyed Manid Hosseiny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 0402
Email address
hosseiny.sm@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of adding garlic to standard treatment for lead poisoning in patients referred to Razi hospital of Ahvaz
Public title
Efficacy garlic in treatment of lead poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
New lead poisoning
Consent to participate in the study
Exclusion criteria:
Presence of serious side effects such as the complications requiring dialysis or seizure, Failure to receive treatment for any reason.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned into two groups. Assignment of patients to the study groups is done by block randomization method and using four blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pharmacological intervention (either garlic or placebo) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also statistical analyzer will not know about patient grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.AJUMS.REC.1397.427
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
Serum lead concentration
Timepoint
At baseline and after treatment
Method of measurement
using laboratory data (atomic absorption spectrometer)
2
Description
Symptoms of lead poisoning
Timepoint
Every week (For 4 weeks)
Method of measurement
Examination and patient history and laboratory data
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: standard treatment and garlic (4 cubes of garlic and penicillamine tablets containing the usual dose of this drug)
Category
Treatment - Drugs
2
Description
Control group: Standard treatment (penicillamine) and placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Ahmad Ghorbani
Street address
Razi Hospital, Felestin St., Amanieh
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Email
Drghorbani07@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8383
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abazar Parsi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8383
Email
Dr-abazar-parsi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abazar Parsi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8383
Email
Dr-abazar-parsi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8383
Email
Dr.mhossieny@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available