Evaluation of the effect of thalidomide on paraquat-induced mortality and measurement of oxidative stress and blood factors
Design
This clinical trial has a control group that will be performed on 30 patients. Patients will be randomly divided into two groups of 15 based on a random number table and will be treated unilaterally.
Settings and conduct
This study is an interventional and clinical trial that will be performed on 30 poisoned people referred to the poisoning ward of Afzalipour Hospital in Kerman.
Due to the fact that both groups receive standard treatment, the intervention group, in addition to standard treatment, also receives thalidomide and is not aware of it.
Participants/Inclusion and exclusion criteria
Paraquat poisoned
Intervention groups
They will receive thalidomide tablets at a dose of 200 mg twice daily (morning and night) for 5 days, and finally the effect of thalidomide on clinical symptoms, liver, lung and kidney function, and changes in mortality will be investigated.
Main outcome variables
Measurement of malondialdehyde
Measurement of glutathione content
Intravenous blood gas levels
Percentage of arterial oxygen saturation
Mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220307054208N1
Registration date:2022-04-26, 1401/02/06
Registration timing:registered_while_recruiting
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
shakiba farhadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5829
Email address
sh.farhadpur@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of thalidomide on paraquat-induced mortality and measurement of oxidative stress and blood factors
Public title
The effect of thalidomide on paraquat-induced mortality and measurement of oxidative stress and blood factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive use of paraquat herbicide with toxic dose (based on history, clinical examination, endoscopic findings)
Patients' satisfaction to participate in the study
Exclusion criteria:
Poisoning with other herbicides other than Paraquat (based on history, clinical examination, endoscopic findings)
Non-toxic dose of paraquat (endoscopy and normal tests)
Lack of cooperation of patients to take medicine due to oral ulcers
Patient dissatisfaction to participate in the study
Existence of underlying lung diseases
Pregnant women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the unit is done by block method with a block size of 4. For each of the 6 possible states for the quadruple block, the numbers are assigned as follows: ABBA (3), ABAB (2), AABB (1), BAAB (6), BABA (5), BBAA (4) using the table Random numbers, numbers between 1 and 6 are selected and the treatment allocation list is specified according to each number.
To execute the generated random sequence, the method of hiding encoded boxes or cans is used. In this method, the cans are numbered according to a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission. Tools: Creating a random sequence of 4 hiding random blocks to execute a random sequence on study participants. How to make: Randomly select the block and read the letters from right to left. The cans are the same weight and shape and will be prepared by an independent researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that both groups receive standard treatment, the intervention group, in addition to standard treatment, receives thalidomide by the head nurse of the ward.
The physician does not know whether patients are receiving or not receiving thalidomide. Placebo thalidomide was not available in this study. Therefore, the study was performed as a one-way blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.KMU.REC.1400.630
Health conditions studied
1
Description of health condition studied
Paraquat herbicide poisoning
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of malondialdehyde
Timepoint
After the intervention
Method of measurement
Spectrophotometry
2
Description
Measurement of glutathione content
Timepoint
After the intervention
Method of measurement
Spectrophotometry
3
Description
Intravenous blood gas levels
Timepoint
After the intervention
Method of measurement
Laboratory experiment
4
Description
Percentage of arterial oxygen saturation
Timepoint
After the intervention
Method of measurement
Laboratory experiment
5
Description
Mortality rate
Timepoint
After the intervention
Method of measurement
Mortality rate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive thalidomide tablets at a dose of 200 mg twice a day (morning and night) for 5 days.
Category
Treatment - Drugs
2
Description
Control group: Common treatments
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital, Kerman
Full name of responsible person
Shakiba Farhadpour
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Educational and Medical Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3132 8000
Email
sh.farhadpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
r_malekpoor@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Shakiba Farhadpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
sh.farhadpur@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shakiba Farhadpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
sh.farhadpur@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shakiba Farhadpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
sh.farhadpur@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
Starting from 6 months after the publication of the article
To whom data/document is available
Researchers, students and doctors
Under which criteria data/document could be used
To conduct a clinical trial
From where data/document is obtainable
General or scientific responsible person
What processes are involved for a request to access data/document
Send the proposal to the email of the person in charge