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IRCT20221206056734N1 IRCT 2023-02-11 Ahvaz University of Medical Sciences Effect of L-carnitine in Ischemic Stroke Effect of L-carnitine supplementation on clinical status, anthropometric indices, and serum levels of some oxidative stress and inflammation biomarkers in ischemic stroke patients. 2023-01-21 anticipated 82 Complete https://irct.ir/trial/67347 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomly assign people to each of the studied groups, block randomization is used. For this study, 7 blocks of 10 and one block of 12 are considered, and an equal number of people from two intervention and control groups are entered in each block. The randomization unit for this study will be individual and for this purpose, a table of random numbers will be used, Blinding description: Supplement and placebo are prepared by Pars Behrozan Jam pharmaceutical company and are labeled with two different letters. All patients, researchers, data analysts and outcome assessors are unaware of the contents of each label until the end of the study. 3 Ischemic stroke. Intervention 1: Intervention group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of L-carnitine 1000 mg per day, prepared by Pars Behrouzan Jam Company, along with meals for 7 days. Patients receiving tube feeding will receive L-carnitine supplementation mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients. Intervention 2: Control group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of double distilled water of 1000 mg per day prepared by Pars Behrouzan Jam Company along with meals for 7 days. Patients receiving tube feeding will receive placebo mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known
public Samaneh Hajjarzadeh
Padad, 12th street, number 82
Ahvaz Iran (Islamic Republic of) 6183986642 +98 61 3553 9049 hajarzadeh70@gmail.com Ahvaz University of Medical Sciences scientific Majid Karandish
Golestan, Esfand street, paramedical faculty of Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 61357159 +98 61 3311 2557 mkarandish@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosing and confirming the occurrence of ischemic stroke through clinical and neurological examinations by a neurologist and brain imaging (CT-Scan or MRI) Be over 18 years old. Body mass index be more than 18.5. Having an NIHSS score of greater than 10 and less than 22. The onset of symptoms be less than 24 hours. Having focal neurologic deficit Insensitivity to L-carnitine supplement No history of previous stroke, craniotomy, and other CNS diseases such as seizures, epilepsy, brain tumor, severe brain injury, multiple sclerosis, Alzheimer's, Parkinson's, etc. Not taking antioxidant or anti-inflammatory supplements or multivitamins in the last three months Not suffering from chronic or acute liver and kidney disorders (kidney failure and dialysis) 18 years no limit Both I63 Cerebral infarction Treatment - Drugs Placebo Intervention group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of L-carnitine 1000 mg per day, prepared by Pars Behrouzan Jam Company, along with meals for 7 days. Patients receiving tube feeding will receive L-carnitine supplementation mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients. Control group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of double distilled water of 1000 mg per day prepared by Pars Behrouzan Jam Company along with meals for 7 days. Patients receiving tube feeding will receive placebo mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients. National Institutes of Health Stroke Scale (NIHSS) score. Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: The scoring checklist is completed through clinical examinations by a specialist. Modified Rankin Scale (mRs) score. Timepoint: Before the intervention, on the seventh day of the intervention and three months after the intervention. Method of measurement: The scoring checklist is completed through clinical examinations by a specialist. Temporal muscle thickness (TMT). Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: Using ultrasound images. C-reactive protein (CRP). Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: blood test. Total Antioxidant Capacity (TAC). Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: blood test. Malondialdehyde (MDA). Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: blood test. Pro-oxidant Antioxidant Balance (PAB). Timepoint: Before the intervention and on the seventh day of the intervention. Method of measurement: blood test. Pars Behrouzan Jam Company Approved 2022-12-03 Ethics Committee of Ahvaz JundiShapur University of Medical Sciences Ahvaz, Golestan, North Esfand St., Ahvaz Jundishapur University of Medical Sciences, Faculty of Paramedicine Ahvaz Khouzestan Iran (Islamic Republic of)