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IRCT20230627058603N1 IRCT 2024-01-03 Esfahan University of Medical Sciences Amitriptyline headache and sleep disorders in patients with mild stroke Investigating the effectiveness of amitriptyline in preventing headache and sleep disorders in patients with mild brainstorming 2023-08-01 anticipated 110 Complete https://irct.ir/trial/71248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Easy sampling methods from those who are eligible to enter the study are randomly divided into two groups of cases and control. In this study, the segmentation of individuals is performed as a quadruple block. In this method A reflects the person who receives the intervention and B represents the person in the control group. Considering the four -block block, we give the AABB Code 0, to the ABAB Code 1, to ABBA Code 2, to BAAB Code 3, to BBAA Code 4 and BABA Code 5 to 9. Then, using the random numbers table, select the starting point randomly and then consider the numbers in a row or column. Considering the order of the table numbers, we replace each number we have hit. Finally, 110 people will be divided into two groups, Blinding description: The researcher does not know which patient received which medicine. In this study, the placebo is just like the original drug and the patient is unaware of which drug he is taking. 1-2 Mild brain trauma. Intervention 1: Intervention group: Amitriptyline from Daropakhsh pharmaceutical company started with a dose of 10 mg and continued up to 50 mg, and according to the patient's tolerance, it was increased to 25 to 50 mg orally within two weeks. Medication lasts for three months. Intervention 2: Control group: Plainboat is prescribed.Medication takes over three months.The manufacturer of placebo is Abidi Pharmaceuticals. 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 There is no further information.
public Mehdi Shafiei
Hazar Jarib Street, Azadi Square
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mui@mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Shafiei
Hazar Jarib Street, Azadi Square
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mui@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction to enter the study Patients with mild strokes with a consciousness coefficient of between 13-15 no limit no limit Both Patients with moderate and high brain trauma Patients with a history of any brain disorders Bipolar and family history Patients with long QT and arrhythmia history Seizure A history of headaches and mood disorders Incidence of any drug complications S06.2 Diffuse traumatic brain injury Prevention Prevention Intervention group: Amitriptyline from Daropakhsh pharmaceutical company started with a dose of 10 mg and continued up to 50 mg, and according to the patient's tolerance, it was increased to 25 to 50 mg orally within two weeks. Medication lasts for three months Control group: Plainboat is prescribed.Medication takes over three months.The manufacturer of placebo is Abidi Pharmaceuticals. Headache. Timepoint: 6 months after intervention. Method of measurement: HDI Standard Headache Questionnaire. Sleep disorders. Timepoint: 6 months after intervention. Method of measurement: Pittsburgh's sleep quality questionnaire. Esfahan University of Medical Sciences Approved 2022-04-23 Ethics committee of Esfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Esfahan Isfehan Iran (Islamic Republic of)