Protocol summary

Summary
The aim of this study was to evaluate the effectiveness of levodopa in early improvement of motor function outcome after ischemic stroke on the track of middle cerebral artery (MCA). A total of 114 patients with ischemic stroke in the middle cerebral artery (MCA), were placed randomly in to carbidopa-levodopa (Levodopa - C) group to 100 mg daily or placebo group. Both groups received standard treatment for stroke as well. Treatment was started immediately after stroke onset and continued until 21 days later. The Rivermead Mobility Index (RMI) and Barthel’s index (BI) of the life quality was used for evaluation of motor deficit at day 22 after treatment. At the end of the third week, with the upper and lower extremity strength differences were compared with each other and at the end of the first month after treatment, the improvement of dysarthria and at the end of the third month after treatment, the presence of spasticity will be review.(at the end of the third week). Inclusion criteria: 1. the patients with ischemic stroke in the MCA territory.2.The absence of another clinical trial simultaneously. Exclusion criteria: 1.major depression, 2.cardiovascular disease 3.tricyclic therapy 4.SSRI therapy 5.dementia.

General information

Acronym
MCA,BI,RMI,CVA.
IRCT registration information
IRCT registration number: IRCT2014042017360N1
Registration date: 2014-10-03, 1393/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-03, 1393/07/11
Registrant information
Name
sepideh Zandifar
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1372 8659
Email address
zandifar-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision between levodopa effect and placebo on the improvement of motor function in the patients with stroke in MCA(Middle cerebral artery),randomized.double blind study.
Public title
The effect of levodopa on stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients with ischemic strroke in the MCA territory. Exclusion criteria: 1.major depression, 2.cardiovascular disease 3.tricyclic therapy 4.SSRI therapy 5.dementia.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 114
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
Ahvaz jundishapour university of medical science
Street address
Central Building, University City, Golestan,Ahvaz
City
ahvaz
Postal code
6135715794
Approval date
2013-04-05, 1392/01/16
Ethics committee reference number
ajums.REC.1392.10

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
G46*
ICD-10 code description
Middle cerebral artery syndrome (I66.0+)

Primary outcomes

1

Description
motor function
Timepoint
three weeks after treatment
Method of measurement
Rivermead mobility index and Barthel index

2

Description
language recovery
Timepoint
4 weeks after treatment
Method of measurement
NIHSSSا

3

Description
Comparision between motor recovery of upper and lower limbs
Timepoint
3 weeks after treatment
Method of measurement
Rivermead mobility index and Barthel index

Secondary outcomes

1

Description
Spastisity
Timepoint
3 months after treatment
Method of measurement
Ashworth modified scale

Intervention groups

1

Description
Intervention group: levodopa-c tablet 1oo/25 mg daily for 21 days in the patients with ischemic stroke in MCA territory.
Category
Treatment - Drugs

2

Description
Control group: placebo tablet 125mr daily for 21 days,in the patients with ischemic stroke in MCA territory.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital, Neurology Emergency Department
Full name of responsible person
Dr. Sepide Zandifar
Street address
Golestan Hospital, Golestan ,Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz jundishapour university of medical science
Full name of responsible person
Research Assistant
Street address
Ajums central building, University City, Golestan, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
u-92017
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz jundishapour university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Alireza Hasanzade
Position
Neurology assistant
Other areas of specialty/work
Street address
Neurolology Department, Golestan Hospital, Golestan, Ahvaz
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
+98 61 1374 3030
Email
hassanzadehar@gmail.com
Web page address
golestanipspital@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Ali Nakhostin Mortazavi
Position
Faculty member
Other areas of specialty/work
Street address
Neurolology Department, Golestan Hospital, Golestan, Ahvaz
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
+98 61 1374 3030
Email
anmortazavi@yahoo.com
Web page address
golestanjpspital@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
AJUMS
Full name of responsible person
Dr. Neda Safapour
Position
MD, internal medicine assistant
Other areas of specialty/work
Street address
Internal Medicine Department, Golestan Hospital, Golestan, Ahvaz
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3011
Fax
+98 61 1374 3030
Email
n1362eda@gmail.com
Web page address
golestanjpspital@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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