Evaluation of Fluoxetine and standard treatment efficacy on change to side effect of stroke of ischemic strokes in both hemisphers in anterior circulation
Aim of this study is evaluation of Fluoxetine efficacy on change to side effect of ischemic strokes in both hemispheres in anterior circulation. This study is clinical trial and double blind. 60 patients with ischemic strokes in both hemispheres in anterior circulation will enter this study. We will divide patients in 4 groups randomly. We will prescribe standard treatment (drugs of Anti platelet and anticoagulant and Statin) and one capsule of 20 milligram Fluoxetine ( Abidi drugs) in 15 patients with ischemic strokes in right hemisphere in intervention group. We will prescribe standard treatment ( drugs of Anti platelet and anticoagulant and Statin) and placebo patients with ischemic strokes in right hemisphere in control group. We treat patient’s with ischemic strokes in left hemisphere as right hemisphere. We complete National Institutes of Health Stroke Scale questionnaire in start study and first one and two months after treatment.
Inclusion criteria: 40-70 years; both of gender; lack of history ischemic strokes and nerve focal defect in last; nerve focal defect in recent ischemic strokes
Exclusion criteria: unavailability of patient during study period; history of side effect of Fluoxetine and other anti psychotic drugs; pregnant woman; lactating women
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041720258N37
Registration date:2017-10-11, 1396/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Arak University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Fluoxetine and standard treatment efficacy on change to side effect of stroke of ischemic strokes in both hemisphers in anterior circulation
Public title
Evaluation of Fluoxetine efficacy on change to side effect of ischemic strokes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 40-70 years; both of gender; lack of history ischemic strokes and nerve focal defect in last; nerve focal defect in recent ischemic strokes; compatibility clinical symptoms of stroke and place conflict brain imaging; select patient in 2-7 days after start ischemic strokes
Exclusion criteria: unavailability of patient during study period; history of side effect of Fluoxetine and other anti psychotic drugs; pregnant woman; lactating women; depression and recent depression in one month ago and treatment with anti psychotic drugs; use Monoamine oxidase inhibitorin five months ago
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
start study and first one and two months after treatment
Method of measurement
National Institutes of Health Stroke Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
We will prescribe patients one capsule of 20 milligram Fluoxetine ( Abidi drugs)and standard treatment ( drugs of Anti platelet and anticoagulant and Statin) in intervention group .
Category
Treatment - Drugs
2
Description
We will treatment patients standard treatment ( drugs of Anti platelet and anticoagulant and Statin) and placebo in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Mohsen Ebrahimi Monfared
Street address
Valiasr Hospital, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences