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IRCT20210307050617N1 IRCT 2021-03-27 Babol University of Medical Sciences Comparison of the effect of fluoxetine and citalopram on motor recovery after ischemic stroke, single-blind clinical trial The efficacy comparison of fluoxetine and citalopram on motor recovery after ischemic stroke: single-blind placebo-controlled randomized clinical trial 2021-03-26 anticipated 90 Complete https://irct.ir/trial/54896 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced (permuted) block randomization with a block size of 30 people and three groups ( A,B,C ), Blinding description: Patients in this study are blind . In this way drugs and placebo are poured into the capsule to match the same size and color, the capsules of each group are poured into cans and given to patients, and the patient is unaware of the type of drug. And the doctor knows what kind of medicine the patient has received (fluoxetine group A, citalopramgroup B, placebo group C ) which is recorded in the patient's demographic information question. 3 Ischemic stroke. Intervention 1: Intervention group 1: The first intervention group is group A, which has 30 patients.They are given fluoxetine capsules made by Aria Company at a dose of 20 mg daily for three months, and at the end of the first, second and third months, the rate of subsequent motor function improvement is evaluated in patients based on the NIHSS motor scale and drug side effects. Intervention 2: Intervention group 2: The second group of intervention is group B. The number of patients in this group is 30. The patients are given citalopram tablets made by Sobhan Pharmaceutical company at a dose of 10 mg in the first 10 days and then 20 mg daily ( which are poured into a capsule to be matched with a fluoxetine capsule) for 3 months.The NIHSS motor scale and drug side effect are assessed at the end of the first, second and third months. Intervention 3: Control group: This group is called group C, which has 30 patients. in addition to the standard treatment for ischemic stroke, placebo, which is starch and is poured into a capsule for assimilation with fluoxetine and citalopram, is given to one capsule daily for 3 months. At the end of the first, second and third months, the rate of improvement in motor function is assessed based on the NIHSS movement scale. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome of the study, which is the rate of improvement in motor function, and its dependent variables When: After completing the study and after publishing the article To whom: Researchers working in academic centers Conditions: The rate of improvement of motor function and analysis of related variables, evaluation of side effects Where to obtain: Email the person in charge and the facilitator How to obtain: Request a study by email and provide sufficient evidence that the applicant is a university researcher. Comments:
public Dr. Payam Saadat
Rouhani hospital, Ganjafroz street, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 2034 sepanta1968@yahoo.com Babol University of Medical Sciences scientific Dr. Payam Saadat
Rouhani hospital, Ganjafroz street, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 2034 sepanta1968@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Hemiparesis or hemiplegia after the first ischemic stroke in 24 hours A score greater than 2 NIHSS scale motion items 18 years no limit Both I63.9 Cerebral infarction, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: The first intervention group is group A, which has 30 patients.They are given fluoxetine capsules made by Aria Company at a dose of 20 mg daily for three months, and at the end of the first, second and third months, the rate of subsequent motor function improvement is evaluated in patients based on the NIHSS motor scale and drug side effects. Intervention group 2: The second group of intervention is group B. The number of patients in this group is 30. The patients are given citalopram tablets made by Sobhan Pharmaceutical company at a dose of 10 mg in the first 10 days and then 20 mg daily ( which are poured into a capsule to be matched with a fluoxetine capsule) for 3 months.The NIHSS motor scale and drug side effect are assessed at the end of the first, second and third months. Control group: This group is called group C, which has 30 patients. in addition to the standard treatment for ischemic stroke, placebo, which is starch and is poured into a capsule for assimilation with fluoxetine and citalopram, is given to one capsule daily for 3 months. At the end of the first, second and third months, the rate of improvement in motor function is assessed based on the NIHSS movement scale. Evaluate the rate of improvement in motor function after receiving the drug after one, two and three months. Timepoint: The patient's motor function is measured every month. The study time on each case is 90 days. Method of measurement: Using the NIHSS scale motion item. University Approved 2020-08-22 Ethics Committee of Babol University of Medical Sciences Rouhani hoapital, Ganjafroz street, Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)