Effect of coenzyme Q10 supplementation on oxidative stress, inflammation, hematology, liver and kidney profiles in organophosphate poisoned patients: a single-blind randomized clinical trial
To assess the effect of coenzyme Q10 supplementation on oxidative stress, inflammation, hematology, liver and kidney profiles in organophosphate poisoned patients
Design
This is a Phase III single-blind randomized clinical trial with a control group with parallel groups, in which 40 eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 40 eligible organophosphate poisoned patients. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Poisoned with organophosphate
Exclusion criteria:
Swallowing disorders
Intervention groups
Intervention group:
Routine treatment for organophosphate poisoning plus one coenzyme Q10 supplement, 100 mg twice daily, for one week
Control Group:
Routine treatment for organophosphate poisoning plus one placebo capsule (starch) twice daily for one week
Main outcome variables
Primary outcome:
Lipid peroxidation level; Total blood antioxidant capacity; Blood thiol group levels; Catalase enzyme activity; CRP level; ESR level; WBC level; RBC level; Hemoglobin level; Triglyceride level; LDL level; HDL level; Urea level; Creatinine level; Albumin level; Protein level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N610
Registration date:2026-05-15, 1405/02/25
Registration timing:prospective
Last update:2026-05-15, 1405/02/25
Update count:0
Registration date
2026-05-15, 1405/02/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-31, 1405/03/10
Expected recruitment end date
2028-05-19, 1407/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 supplementation on oxidative stress, inflammation, hematology, liver and kidney profiles in organophosphate poisoned patients: a single-blind randomized clinical trial
Public title
Effect of coenzyme Q10 supplementation on oxidative stress, inflammation, hematology, liver and kidney profiles in organophosphate poisoned patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Poisoned with organophosphate
Exclusion criteria:
Swallowing disorders
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Therefore, the trial will be conducted as a single-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Avev
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2026-05-09, 1405/02/19
Ethics committee reference number
IR.UMSHA.REC.1405.113
Health conditions studied
1
Description of health condition studied
Organophosphate poisening
ICD-10 code
T60.0
ICD-10 code description
Toxic effect of organophosphate and carbamate insecticides
Primary outcomes
1
Description
Lipid peroxidation level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Using TBA reagent at a wavelength of 532 nm by a spectrophotometer
2
Description
Total blood antioxidant capacity
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Using TPTZ reagent at a wavelength of 593 nm by a spectrophotometer
3
Description
Blood thiol group levels
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Using DTNB reagent at a wavelength of 412 nm by a spectrophotometer
4
Description
Catalase enzyme activity
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Using H₂O₂ reagent and sodium phosphate buffer at a wavelength of 240 nm by a spectrophotometer
5
Description
CRP level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
6
Description
ESR level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
7
Description
WBC level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
8
Description
RBC level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
9
Description
Hemoglobin level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
10
Description
Triglyceride level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
11
Description
LDL level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
12
Description
HDL level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
13
Description
Urea level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
14
Description
Creatinine level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
15
Description
Albumin level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
16
Description
Protein level
Timepoint
Before the intervention and one week after the intervention
Method of measurement
By collecting and testing a blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment for organophosphate poisoning plus one coenzyme Q10 supplement, 100 mg twice daily, for one week
Category
Treatment - Drugs
2
Description
Control Group: Routine treatment for organophosphate poisoning plus one placebo capsule (starch) twice daily for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Freshteh Mehri
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
freshteh_mehri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Freshteh Mehri
Position
Toxicologist
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
freshteh_mehri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Freshteh Mehri
Position
Toxicologist
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
freshteh_mehri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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