survey the effect of Omega-3 prescription on serum levels of Interleukin-6 and Interleukin-1 beta in patients with traumatic brain injury
Design
In a randomized double-blind phase 3 clinical trial study, 80 patients were randomly divided into two groups of 40 patients who receiving omega-3 and placebo capsule every night for 7 days. then On the seventh day, Glasgow Coma Scale and serum levels of IL-6 and IL-I beta will be measured in two groups
Settings and conduct
80 patients with traumatic brain injury referred to Ahvaz Imam Khomeini Hospital were divided into two groups receiving oral omega-3 capsules and placebo capsule recipients but this capsule encoded and patient and the person who evaluating patient don't know the kind of drug. after 7 days Glasgow Coma Scale and serum levels of IL-6 and IL-I beta will be measured in two groups
Participants/Inclusion and exclusion criteria
inclusion criteria is Patients with traumatic brain injury and exclusion criteria is history of seafood susceptibility, history of severe and uncontrollable hypertension, consumption of immunosuppression, consumption of antiepileptic, liver dysfunction and Kidney disorder
Intervention groups
Oral Omega-3 capsule recipient group
normal saline placebo capsule recipient group
Main outcome variables
Glasgow Coma Scaleو serum levels of IL-6 and IL-I beta
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038838N1
Registration date:2018-03-10, 1396/12/19
Registration timing:prospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Fereshteh Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 8989
Email address
amiri.fe@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Omega-3 prescription on serum levels of Interleukin-6 and Interleukin-1 beta in patients with traumatic brain injury
Public title
The Effect of Omega-3 prescription on serum levels of Interleukin-6 and Interleukin-1 beta in patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with traumatic brain injur
Exclusion criteria:
History of seafood susceptibility
History of severe and uncontrollable hypertension
Consumption of immunosuppression
Consumption of antiepileptic
Liver Dysfunction
Kidney disorder
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Use of the same coded capsule and then patients and the clinical elevators do not know the kind of drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.AJUMS.REC.1396.926
Health conditions studied
1
Description of health condition studied
traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Glasgow Coma Scale
Timepoint
Before the intervention and seven days after the intervention
Method of measurement
Glasgow coma scale score
2
Description
Serum level of interleukin-6
Timepoint
Before the intervention and seven days after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA )
3
Description
Serum level of interleukin-1 beta
Timepoint
Before the intervention and seven days after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of oral Omega 3 capsule