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IRCT20230627058603N2 IRCT 2024-01-04 Esfahan University of Medical Sciences Rosuvastatin in patients with moderate brain trauma Investigating the effectiveness of Rosuvastatin in patients with moderate brain trauma 2023-12-22 anticipated 200 Complete https://irct.ir/trial/73461 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are placed in 2 groups by random block method. In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block, 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. 2 Moderate traumatic brain injury. Intervention 1: Intervention group: Rosuvastatin with a dose of 20 mg (which is equivalent to 40 mg of Atorvastatin and 80 mg of Simvastatin) (21, 20) will be prescribed to patients daily for ten days. Intervention 2: Control group: They will receive a placebo (an ineffective substance made from the Faculty of Pharmacy, similar to Rosuvastatin , used daily for ten days) 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
Isfahan 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
Isfahan 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 level of consciousness between 8-12 Informed consent of first-degree companions to enter the study no limit no limit Both History of any brain disorders Normal Liver function tests S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: Rosuvastatin with a dose of 20 mg (which is equivalent to 40 mg of Atorvastatin and 80 mg of Simvastatin) (21, 20) will be prescribed to patients daily for ten days. Control group: They will receive a placebo (an ineffective substance made from the Faculty of Pharmacy, similar to Rosuvastatin , used daily for ten days) 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 2022-06-15 Ethical Committee of Faculty of Medicine, Isfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)