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IRCT20190618043934N18 IRCT 2023-07-14 Birjand University of Medical Sciences The effect of amantadine on the recovery of patients with traumatic brain injury The effect of amantadine on the recovery of patients with severe brain injury: a randomized controlled clinical trial 2023-08-22 anticipated 51 Complete https://irct.ir/trial/71259 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups by simple randomization and block method: 1. Amantadine recipient (A) and 2. Placebo recipient (B). The selection and placement of patients in two groups will be simple random and blocked in a closed and sealed envelope. In this way, various quadruple blocks are created first (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks will be randomly selected and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well, Blinding description: Participant in the study: due to the fact that the patients are not conscious, they will not know about the prescribed medicine for them. Outcome evaluator: The study administrator, without knowing the type of drug received, asks questions from the patients and records them in the relevant checklist. Analyst: The person who is responsible for data analysis will not know about the placement of patients in each group and the data will be analyzed blindly. 3 brain injury. Intervention 1: Intervention group: The first intervention group: Group A receiving amantadine 100 mg twice a day (8:00 a.m. to 8:00 p.m.) for 6 weeks. Intervention 2: Control group: The first control group: Group B receiving placebo containing fructose for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no need to publish individual patient information
public Zabihullah Mohaqiq
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3232 3232 oabstudent@gmail.com Birjand University of Medical Sciences scientific Dr Kazem Ghaemi
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717811674 +98 56 3232 3232 oabstudent@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Age more than 16 years GCS≤8 Possibility of receiving medicine through NG or OG tube Obtaining consent from the patient to enter the study after she regains consciousness and recovers(مؤنث) 16 years no limit Both Pregnancy Diabetes disease Dyslipidemia Cancer Congenital, ischemic and atherosclerotic heart disease Kidney failure Patients with unknown identity Kidney disease Use of dopanergic agents by the patient Contraindications for the use of amantadine S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: The first intervention group: Group A receiving amantadine 100 mg twice a day (8:00 a.m. to 8:00 p.m.) for 6 weeks. Control group: The first control group: Group B receiving placebo containing fructose for 6 weeks. Glasgow Coma Scale. Timepoint: First and before the intervention, the third day of the intervention and the seventh day of the intervention. Method of measurement: Using the Glasgow coma criteria table and clinical examination by a neurosurgery assistant. Birjand University of Medical Sciences Approved 2022-07-24 Ethics Committee of Birjand University of Medical Sciences Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town Birjand South Khorasan Iran (Islamic Republic of)