The effect of Oleoyl ethanolamide (OEA) supplementation on blood hematological parameters, lipid profile, biomarkers of oxidative stress and inflammatory parameters in the blood of patients with acute ischemic brain stroke
Effect of Oleoyl ethanolamide supplementation on hematologic parameters, lipid profile, inflammatory parameters and oxidative stress biomarkers in patients with acute ischemic stroke
Design
40 patients Individually were divided into two groups by the simple randomization method and by the decimal number table and receiving Oleoyl ethanolamide supplementation.
Clinical trial with control group, With parallel groups, Three blind strains, Accidental
Settings and conduct
40 patients referred to Sina Hospital of Hamadan (consecutively) diagnosed with a physician with acute ischemic stroke were randomly divided into two groups with Allocation Concealment. Blinding of all organs as patients know only by computer code. Therapeutic codes are revealed at the end of the study and it is unclear whether the placebo or supplement is taken because the placebo capsules will be made to look very similar to Oleoyl ethanolamide. . Patients receive written consent to participate in the study and to participate in the sampling. After intervention, blood sample is taken and examined.
Participants/Inclusion and exclusion criteria
Entry requirements:
Willingness to cooperate
Acute ischemic stroke
Exclusion criteria:
taking immunosuppressive drugs
History of rheumatic and collagen and vascular diseases
History of recent infections (within 2 to 3 months)
Swallowing disorders that are unable to take medication
Sensitivity to compounds
No regular use of supplements
Not willing to cooperate
Diabetes
kidney disease
Intervention groups
The intervention group received a daily supplement of Oleoyl ethanolamide (200 mg) along with main meals for 2 months.
The control group should also take a placebo capsule daily for 2 months.
Main outcome variables
Hematologic parameters, lipid profile, inflammatory parameters and oxidative stress biomarkers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130501013194N4
Registration date:2019-12-28, 1398/10/07
Registration timing:prospective
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Akram Ranjbar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0031
Email address
a.ranjbar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Oleoyl ethanolamide (OEA) supplementation on blood hematological parameters, lipid profile, biomarkers of oxidative stress and inflammatory parameters in the blood of patients with acute ischemic brain stroke
Public title
The effect of Oleoyl ethanolamide (OEA) supplementation in patients with acute ischemic brain stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Acute ischemic brain stroke (preferably under one month)
Exclusion criteria:
taking immunosuppressive drugs
History of rheumatic and collagenvascular diseases
History of recent infections (within 2 to 3 months)
Swallowing disorders that are unable to take medication
Sensitivity to compounds
No regular use of supplements
Not willing to cooperate
Diabetes
kidney disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
This is an interventional study with a randomized controlled trial study design. In this study, 40 patients referred to Sina Hospital of Hamadan (consecutively) with diagnosis of acute ischemic stroke physician will be included in the study. In this study, patients were randomly divided into two groups of Oleoyl ethanolamide and placebo with Allocation Concealment by random number table and based on their group of supplements receive the relevant for two months. They will receive a computer code. The personal code of any participant in this course of treatment is not disclosed. Treatment codes are revealed at the end of the study after the database is closed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants receive the relevant supplements for two months after obtaining written consent from the group in which they are located. They will receive a computer code. The personal code of any participant in this course of treatment is not disclosed. Treatment codes are revealed at the end of the study after the database is closed. Capsules and placebo are similar in appearance, so clinical caregivers, researchers, outcome assessors and data analysts and the Committee on Safety and Data Monitoring know patients only by code and do not know which patient received the supplement or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hamedan University of Medical Sciences
Street address
Fahmedeh Blvd., Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-12-06, 1398/09/15
Ethics committee reference number
IR.UMSHA.REC.1398.720
2
Ethics committee
Name of ethics committee
Ethic committee of Hamedan University of Medical Sciences
Street address
Fahmedeh Blvd., Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.721
3
Ethics committee
Name of ethics committee
Ethic committee of Hamedan University of Medical Sciences
Street address
Fahmedeh Blvd., Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.722
Health conditions studied
1
Description of health condition studied
Acute ischemic brain stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Red blood cells
Timepoint
Before and after intervention
Method of measurement
Laboratory
2
Description
White blood cells
Timepoint
Before and after intervention
Method of measurement
Laboratory
3
Description
Platelets
Timepoint
Before and after intervention
Method of measurement
Laboratory
4
Description
Alanine aminotransferase
Timepoint
Before and after intervention
Method of measurement
Laboratory
5
Description
Aspartate aminotransferase
Timepoint
Before and after intervention
Method of measurement
Laboratory
6
Description
Cholesterol
Timepoint
Before and after intervention
Method of measurement
Laboratory
7
Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Laboratory
8
Description
High density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Laboratory
9
Description
Low density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Laboratory
10
Description
Urea
Timepoint
Before and after intervention
Method of measurement
Laboratory
11
Description
Creatinine
Timepoint
Before and after intervention
Method of measurement
Laboratory
12
Description
Lipid peroxidation
Timepoint
Before and after intervention
Method of measurement
Using spectrophotometer
13
Description
Protein oxidation
Timepoint
Before and after intervention
Method of measurement
Using spectrophotometer
14
Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
Using spectrophotometer
15
Description
Catalase activity
Timepoint
Before and after intervention
Method of measurement
Using spectrophotometer
16
Description
Tumor necrosis factor alpha
Timepoint
Before and after intervention
Method of measurement
ELISA
17
Description
Interleukin 17
Timepoint
Before and after intervention
Method of measurement
ELISA
18
Description
Reactive Protein C
Timepoint
Before and after intervention
Method of measurement
Turbidometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They take one oleoyl ethanolamide supplement (200 mg) daily for two months. Supplements are made by Karen.
Category
Treatment - Drugs
2
Description
Control group: They receive a placebo capsule daily (a capsule that is not Oleoyl ethanolamide but patients are not told) for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mojtaba Khazaei
Street address
Mirzadeh Eshqi St, Sina Hospital
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 4191
Email
a.ranjbar@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmedeh Blvd., Hamedan university of medical sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3525 0182
Email
a.ranjbar@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
Akram Ranjbar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Fahmedeh Blvd., Hamedan university of medical sciences
City
Hamdan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3827 4191
Email
a.ranjbar@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Ranjbar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Fahmedeh Blvd., Hamedan university of medical sciences
City
Hamdan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3827 4191
Email
a.ranjbar@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Ranjbar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmide Street, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 1838 0031
Fax
+98 81 1838 0031
Email
a.ranjbar@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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available