]>
IRCT20241229064208N2 IRCT 2025-10-14 Oroumia University of Medical Sciences Effect of melatonin in patients with ischemic stroke Comparison of the effect of melatonin versus placebo on infarct size in patients with ischemic stroke 2025-12-22 anticipated 40 Complete https://irct.ir/trial/86383 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Forty patients will be randomly assigned to two groups: intervention and control. Randomization will be performed using block randomization. First, blocks of size 5 with the sequence (ABABA) will be listed, and each block will be assigned a code. Based on the total sample size of 40, 8 blocks will be selected, and patients will be assigned to the intervention and control groups according to these codes, Blinding description: This study will be conducted in a single-blinded manner, so that the form of the drugs and placebo will be completely identical and the patient will not know the type of intervention.and control groups. 1-2 Acute Ischemic Stroke. Intervention 1: Intervention group: Routine treatment includes antiplatelet and atorvastatin plus melatonin tablets 20 mg daily for 5 days. Intervention 2: Control group: Routine treatment with placebo tablets containing starch (made by the Faculty of Pharmacy) 20 mg daily for 5 days. 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 will make a decision to publish after the completion of the project and according to the results
public Dr. Rizvan Norouzzadeh
Imam Khomeini University Hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 norouzzade.r@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Rizvan Norouzzadeh
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 norouzzade.r@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age 18 to 80 years Ability and willingness to participate in the study (obtaining informed consent) Acute stroke that occurred within 7 days prior to admission to the ward Diagnosis of acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) at the time of admission 18 years 80 years Both Patient with a history of heart attack Primary hemorrhagic stroke Pre-stroke diagnosis indicating significant decline in mental function or impairment A valid neurological disease in addition to stroke, such as Parkinson's disease Severe liver, kidney, or thyroid disease, or heart failure, respiratory failure, or other organ failure Chronic inflammatory diseases, immune or hematological disorders History of depression (clinical diagnosis or previous treatment) or other mental disorders Patients who are not accessible I63.9 Cerebral infarction, unspecified Treatment - Drugs Placebo Intervention group: Routine treatment includes antiplatelet and atorvastatin plus melatonin tablets 20 mg daily for 5 days. Control group: Routine treatment with placebo tablets containing starch (made by the Faculty of Pharmacy) 20 mg daily for 5 days • Size of cerebral infarction (volume of ischemic area). Timepoint: 1. Baseline (before intervention) – in the first 7 days after stroke and before treatment begins, 2. Follow-up (follow-up) – three months after intervention. Method of measurement: Brain CT scan. Oroumia University of Medical Sciences Approved 2025-07-30 Research Ethics Committee of Imam Khomeini Educational and Medical Center, Urmia University of Medic Imam Khomeini University Hospital, Ershad Ave, Modarres Blvd, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)