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

We decided to investigate the effect of acetylcysteine NAC on TBI patients and to investigate its effectiveness to reduce the side effects of TBI.

A clinical trial with a control group, with parallel groups, double-blind, randomized block type, phase 3 on 60 referring patients from October 1402 to October 1403

This study was in the form of a clinical trial, in which it was a double-blind study of patients with moderate to severe traumatic brain injury who referred to the 7th Hospital from October 2023 to October 2024randomly divided into two groups A and B, and NAC drug with an oral dose 3.6 grams for 4 days and then 1.8 mg for 3 days were given to the patients and a placebo drug group was given in an unspecified manner for the researchers and clinical nurses of the patients. (To each of the groups The study subject is given a drug (placebo or NAC) and the type of drug given remains in a sealed envelope until the end of the study, and at the end and after data analysis, the envelopes are returned to determine the type of drug given to each group)

Patients over 18 years of age with moderate to severe traumatic brain injury should refer to Haftam Tir Hospital from October 2023 to October 2024 . If the Glasgow coma scale is 3, they are not included in the study

NAC with an oral dose of 3.6 grams for 4 days and then 1.8 mg for 3 days was given to the patients in the intervention group, and placebo was given to the control group. Then the level of consciousness of the patients is re-evaluated after 7 days and the outcome of the use of medicine is evaluated.

The effect of N-acetylcysteine on the prognosis of patients with moderate to severe traumatic brain injury

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.

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

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

Start access period 6 months after printing results

Researchers working in academic and scientific institutions

To refer the contents

Mohammad Hossein Ghazvini mobile number 09128882826 and 02122465720 and ghazvinimohammadhossein@gmail.com and address in Tehran, Shahr-e Rey , Haftome Tir Hospital

After receiving the request and not inconsistent with the information received, the data will be sent to the applicant within 2-3 business days