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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014042017360N1 |
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Date of registration:
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2014-10-03 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of levodopa on stroke
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Scientific title:
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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. |
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Date of first enrolment:
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2013-04-04 |
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Target sample size:
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114 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/15980 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Ali Nakhostin Mortazavi
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Address:
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Neurolology Department, Golestan Hospital, Golestan, Ahvaz
6135733118
Ahvaz
Iran (Islamic Republic of) |
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Telephone:
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+98 61 1374 3012 |
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Email:
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anmortazavi@yahoo.com |
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Affiliation:
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Ahvaz Jondishapour University of Medical Sciences |
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Name:
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Dr. Alireza Hasanzade
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Address:
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Neurolology Department, Golestan Hospital, Golestan, Ahvaz
6135733118
Ahvaz
Iran (Islamic Republic of) |
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Telephone:
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+98 61 1374 3012 |
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Email:
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hassanzadehar@gmail.com |
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Affiliation:
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Ahvaz Jondishapour University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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.
Exclusion criteria:
Age minimum:
no limit
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ischemic stroke.
Middle cerebral artery syndrome (I66.0+)
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Middle cerebral artery syndrome (I66.0+)
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Intervention(s)
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Intervention group: levodopa-c tablet 1oo/25 mg daily for 21 days in the patients with ischemic stroke in MCA territory.
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Intervention 1: Intervention group: levodopa-c tablet 1oo/25 mg daily for 21 days in the patients with ischemic stroke in MCA territory. Intervention 2: Control group: placebo tablet 125mr daily for 21 days,in the patients with ischemic stroke in MCA territory.
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Control group: placebo tablet 125mr daily for 21 days,in the patients with ischemic stroke in MCA territory.
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Placebo
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Treatment - Drugs
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Primary Outcome(s)
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Language recovery. Timepoint: 4 weeks after treatment. Method of measurement: NIHSSS?.
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Comparision between motor recovery of upper and lower limbs. Timepoint: 3 weeks after treatment. Method of measurement: Rivermead mobility index and Barthel index.
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Motor function. Timepoint: three weeks after treatment. Method of measurement: Rivermead mobility index and Barthel index.
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Secondary Outcome(s)
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Spastisity. Timepoint: 3 months after treatment. Method of measurement: Ashworth modified scale.
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Source(s) of Monetary Support
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Ahvaz jundishapour university of medical science
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Ethics review
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Status: Approved
Approval date:
Contact:
Ahvaz jundishapour university of medical science
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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