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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: |
IRCT2014032113947N4 |
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Date of registration:
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2014-07-16 |
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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 Effects of Atorvastatin on Spinal Cord Injury
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Scientific title:
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The Effects of Atorvastatin on Motor and Sensory Function of Patients with Post- Traumatic Acute Spinal Cord Injury. |
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Date of first enrolment:
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2014-05-22 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/13664 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Triple 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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Atta Mahdkhah
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Address:
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NO.20, Allame Amini Ave., Valiasr St., Tabriz, Iran
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1332 6196 |
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Email:
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mahdkhah@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: 1. Age: 18-70 years; 2. Weight: 60-80kg; 3. Informed consent; 4. Matched clinical and imaging findings; 5.C4 to L2 vertebral fractures; 6. Frankel Impairment Scale level A, B or C
Exclusion criteria: 1. Pregnancy; 2. Lactation; 3. History of depression; 4. History of seizure; 5. History of diabetes, hepatic disorder or cardiovascular disease; 6. Aphasia or visual loss; 7.Unable to receive atorvastatin orally
Exclusion criteria:
Age minimum:
18 years
Age maximum:
70 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Injury of spinal cord, level unspecified
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Spinal cord injury.
Injury of spinal cord, level unspecified
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Intervention(s)
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Placebo
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Each of participant in case-group will be received Atorvastatin 20mg orally every 12 hours.
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Intervention 1: Each of participant in case-group will be received Atorvastatin 20mg orally every 12 hours. Intervention 2: In the control group, each patient will be received a placebo tablets orally every 12 hours. These capsules have similar shape, color, weight of atorvastatin ones.
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In the control group, each patient will be received a placebo tablets orally every 12 hours. These capsules have similar shape, color, weight of atorvastatin ones.
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Treatment - Drugs
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Primary Outcome(s)
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Lumbar back pain. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: V.A.S (visual analog scale).
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Sensory and motor condition. Timepoint: Primary, 6 weeks and months following treatment. Method of measurement: Frankel classification.
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Secondary Outcome(s)
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Hepatic Injury. Timepoint: Primary, 6 weeks and 6 months following treatment. Method of measurement: Liver Function Tests.
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Source(s) of Monetary Support
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Vice Chancellor for research of Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Tabriz University of Medical Sciences
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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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