Protocol summary

Summary
In this study, 64 patients with supratentorial ischemic stroke will evaluated. For all patients within 24 hours of admission, transcranial doppler sonography will do and after that the patients will be divided into two equal groups and for a week, one group will be treated with citicoline 500 mg daily and the second group with placebo and again transcranial doppler sonography will do and the data will analyze .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201705278430N9
Registration date: 2017-06-21, 1396/03/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Farhad Iranmanesh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 2629
Email address
fpp_farhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kerman Medical University
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of citicoline on cerebrovascular hemodynamic status in ischemic stroke patients and comparison with control group
Public title
Effects of citicoline on cerebrovascular hemodynamic status in ischemic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Supratentorial ischemic stroke ; stroke within 24 hours of admission Exclusion criteria:Embolic stroke ; lacunar infarction ;Trombolyticthrapy;Drug sensitivity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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 of Kerman Medical University
Street address
Kerman Haft bagh road
City
Kerman
Postal code
Approval date
2015-04-25, 1394/02/05
Ethics committee reference number
IR.Kmu.REC.1394.735

Health conditions studied

1

Description of health condition studied
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
Peak systolic velocity and Mean flow velocit
Timepoint
first and 7th day
Method of measurement
cm / sec by Dopller sonography

Secondary outcomes

1

Description
increase blood filow
Timepoint
first and 7th day
Method of measurement
Peak systolic velocity and Mean flow velocity by sonography

Intervention groups

1

Description
Intervention group : 500 ml Iv citicoline daily for a week
Category
Treatment - Drugs

2

Description
Control group:Placebo for a week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Farhad Iranmanesh
Street address
Shafa hospital,Shafa Street,Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neurology Research Center, Kerman Medical University
Full name of responsible person
Elham Khadir
Street address
Shafa hospital,Shafa street,Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurology Research Center, Kerman Medical University
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
Kerman Medical University
Full name of responsible person
Rostam Seifaddini
Position
Assistant
Other areas of specialty/work
Street address
Shafa hospital,Shafa hospital,Kerman
City
Kerman
Postal code
Phone
+98 34331217409
Fax
Email
r.seifaddini@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman Medical University
Full name of responsible person
Akbar Hamzeimoghadam
Position
Professor
Other areas of specialty/work
Street address
Shafa hospital,Shafa street,Kerman
City
Kerman
Postal code
Phone
+98 34331217409
Fax
Email
Dr.akbar2012@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman Medical University
Full name of responsible person
Farhad Iranmanesh
Position
Professor
Other areas of specialty/work
Street address
Shafa hospital,Shafa street,Kerman
City
Kerman
Postal code
Phone
00
Fax
Email
fpp_farhad@yahoo.com
Web page address

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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