The aim of this study is to investigate the effect of IMOD (Setarud) on clinical signs and symptoms and inflammatory factors in patients with acute ischemic stroke. In this parallel randomized controlled trial patients with acute ischemic stroke will be randomized into two groups during first 24 hours of symptom onset. Patients with prior neurological deficit of any cause, cancer or any other severe disease, rapidly improving symptoms prior to intervention, NIHSS less than 5 at presentation and concurrent immunosuppressive/immunomodulator drug use will be excluded. Patients of control group will receive routine treatment based on ward protocol and patients of intervention group will receive routine treatment plus IMOD infusion for total seven days. Serum levels of TNF-alpha, IL-1 and IL-6 and WBC, platelet and CRP will be measured at first, fourth and seventh days and NIHSS & MRS will be assessed at first and seventh days and third month after disease presentation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108202195N2
Registration date:2011-10-15, 1390/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-15, 1390/07/23
Registrant information
Name
Mehdi Farhoudi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41100983340730
Email address
farhoudim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Neuroscience Research Center, Vice chancellor for research, Tabriz University of Medical Sciences
2- Pars Roos Company
Expected recruitment start date
2011-10-12, 1390/07/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of IMOD (Setarud) on the National Institute of Health Stroke Scale (NIHSS) in acute ischemic stroke
Public title
Effect of IMOD in the treatment of stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with acute ischemic stroke (based on clinical and imaging findings)
Exclusion criteria: age less than 18years or more than 80 years, prior neurological deficit of any cause, cancer or any other severe disease, rapidly improving symptoms prior to intervention, NIHSS less than 5 at disease presentation, symptom onset less than 3 hours or more than 24 hours, no informed consent, concurrent immunosuppressive / immunomodulator drug use.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz, Iran
City
Tabriz
Postal code
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
5/4/3690
Health conditions studied
1
Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
occlusion and stenosis of cerebral and precerebral arteries, resulting in cerebral infarction
Primary outcomes
1
Description
Neurological outcome of Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
2
Description
Functional outcome of Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
Modified Rankin Scale (MRS)
3
Description
Arm Motor deficit following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
4
Description
Sensory deficit following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
5
Description
Facial palsy following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
6
Description
Leg Motor deficit following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
7
Description
Best Language following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
8
Description
Dysarthria following Acute Ischemic Stroke
Timepoint
Prior to intervention, days 7 & 90 after symptom onset
Method of measurement
National Institute of Health Stroke Scale (NIHSS)
Secondary outcomes
1
Description
IL-1
Timepoint
Prior to intervention and days 4 & 7 after symptom onset
Method of measurement
ELISA
2
Description
IL-6
Timepoint
Prior to intervention and days 4 & 7 after symptom onset
Method of measurement
ELISA
3
Description
Relative Frequency of Hemorrhagic Complications
Timepoint
7th day after symptom onset
Method of measurement
Spiral Brain CT scan
4
Description
Relative Frequency of Infectious Complications
Timepoint
7th day after symptom onset
Method of measurement
Blood Culture; Urine Culture; CXRay alterations
5
Description
Survival
Timepoint
90th day after symptom onset
Method of measurement
Kaplan-Meier survival curves
6
Description
TNF-alpha
Timepoint
Prior to intervention and days 4 & 7 after symptom onset
Method of measurement
ELISA
7
Description
WBC
Timepoint
Prior to intervention and days 4 & 7 after symptom onset
Method of measurement
Cell count
8
Description
platelet
Timepoint
Prior to intervention and days 4 & 7 after symptom onset
Method of measurement
Cell count
Intervention groups
1
Description
Routine treatment for Acute Ischemic Stroke (based on ward protocol) plus Daily infusion of IMOD (Herbal extract of Tanacetum Vulgare, Rosa Canina and Urtica dioica enriched with Selenium, 120 mg/4cc) 8cc at first day & 12cc at following days in serum DW5 over 30min for total 7days
Category
Treatment - Drugs
2
Description
Routine treatment for Acute Ischemic Stroke (based on ward protocol)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Center
Full name of responsible person
Dr. Mehdi Farhoudi
Street address
Neurosciences Research Center, Gholghasht Street
City
Tabriz
2
Recruitment center
Name of recruitment center
Razi Medical Center
Full name of responsible person
Dr. Mahdi Najafi Nesheli
Street address
El-Gholi Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences