]>
IRCT20221108056446N5 IRCT 2023-11-27 Esfahan University of Medical Sciences Melatonin in medium brain trauma Investigation of Melatonin Therapeutic Effect in Patients with Moderate Brain Trauma 2023-12-22 anticipated 200 Complete https://irct.ir/trial/73757 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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, 3 people will be divided into two groups, Blinding description: In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed. 2 Moderate brain trauma. Intervention 1: Intervention group: Melatonin treatment is started for the first 48 hours to 72 hours immediately after the patient's gavage. Three milligrams daily (once a day) is prescribed for the patient before going to bed. Intervention 2: Control group: They will receive a placebo (an ineffective substance made in the Faculty of Pharmacy similar to Melatonin daily for 5 months) in the same way as the case group. 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) Patients with a consciousness coefficient between 9 and 13 Conscious consent of first -degree companions to enter the study no limit no limit Both A history of any brain disorders Liver function tests normal Previous use of melatonin. S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: Melatonin treatment is started for the first 48 hours to 72 hours immediately after the patient's gavage. Three milligrams daily (once a day) is prescribed for the patient before going to bed. Control group: They will receive a placebo (an ineffective substance made in the Faculty of Pharmacy similar to Melatonin daily for 5 months) in the same way as the case group. Improve the state of Glasgow Coma Scale (GCS). Timepoint: One, three and 6 months after the injury. Method of measurement: Glasgow coma scale. Esfahan University of Medical Sciences Approved 2023-05-30 Ethics committee of Esfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Esfahan Isfehan Iran (Islamic Republic of)