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IRCT20230815059150N1 IRCT 2023-09-02 Iran University of Medical Sciences Effect of N-acetylcysteine in moderate to severe traumatic brain injury Investigating the effect of N-acetylcysteine ​​on the prognosis of patients with moderate to severe traumatic brain injury who referred to the Hafte Tir Hospital from October 1402 to October 1403 2023-09-22 anticipated 60 Complete https://irct.ir/trial/72160 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done in the form of standard block randomization and the use of sealed envelopes in such a way that each patient referred to the study entry conditions is numbered starting from 1 and then divided into two groups A and B is divided and then medicine or placebo is given to each of these groups. After studying the sealed envelope, it is returned for data analysis and it is determined which group was given medicine and which group was given placebo, Blinding description: In this study, the blinding method is double-blind, in which the patient, the clinical caregiver, and the researcher are kept blind, in this way that after randomizing the patients with the block randomization method, the people mentioned above is unknown about receive either the drug or the placebo therapeutic intervention of each group A and B . After collecting the data, the sealed envelope that specifies the type of therapeutic intervention is opened by the data analyst. 3 Traumatic Brain Injury. Intervention 1: Intervention group: N-acetylcysteine (NAC) drug is given to patients orally with an oral dose of 3.6 grams for 4 days and then 1.8 mg for 3 days. Intervention 2: Control group: The placebo is taken orally and the same as the intervention group. Yes - There is a plan to make this available What will be shared: This study will be blinded for the patient and the researcher. After assigning people to the arms, the type of intervention on the person's questionnaire will be in the form of options A (main intervention) and B (control intervention) and the analyst will report the results as a difference between the two groups A and B after completing the analysis. will give and then the sealed envelope that shows the type of intervention of each group will be opened. After data collection, data will be analyzed by SPSS ver. 25 statistical software. Continuous quantitative variables will be reported by central dispersion indices (mean and standard deviation). K-S test will also be used to determine the normality of data distribution. Student T Test and Chi Square Test will be used for analysis between groups. P < 0.05 will be considered as a significant level for all tests When: Start access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: To refer the contents Where to obtain: Mohammad Hossein Ghazvini mobile number 09128882826 and 02122465720 and ghazvinimohammadhossein@gmail.com and address in Tehran, Shahr-e Rey , Haftome Tir Hospital How to obtain: After receiving the request and not inconsistent with the information received, the data will be sent to the applicant within 2-3 business days Comments:
public Mohammad Hossein Ghazvini
No.44 , Kangan Ave , Kangan Blvd , Artesh Blvd
Tehran Iran (Islamic Republic of) 1955646371 +98 21 2246 5720 ghazvinimohammadhossein@gmail.com Iran University of Medical Sciences scientific Mohammad Hossein Ghazvini
No. 44 , Kangan Ave , Kangan Blvd , Artesh Blvd
Tehran Iran (Islamic Republic of) 1955646371 +98 21 2246 5720 ghazvinimohammadhossein@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with moderate to severe traumatic brain injury Patients over 18 years of age 18 years no limit Both Patients with Glasgow Coma Scale 3 S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: N-acetylcysteine (NAC) drug is given to patients orally with an oral dose of 3.6 grams for 4 days and then 1.8 mg for 3 days. Control group: The placebo is taken orally and the same as the intervention group The effect of NAC on the Glasgow Coma Scale (GCS) of patients with moderate to severe traumatic brain injury. Timepoint: 7 Days. Method of measurement: table of Glasgow Coma Scale. The effect of NAC on the Glasgow Outcome Scale (GOS) of patients with moderate to severe traumatic brain injury. Timepoint: 7 Days. Method of measurement: Table of Glasgow Outcome Scale. The effect of NAC on the Modified Rankin Scale (mRS) of patients with moderate to severe traumatic brain injury. Timepoint: 7 days. Method of measurement: Table of Modified Rankin Scale (mRS). Iran University of Medical Sciences Approved 2023-08-28 Ethics committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower Tehran Tehran Central African Republic