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IRCT20240720062482N1 IRCT 2024-10-13 Karaj University of Medical Sciences Investigating the efficacy of simultaneous administration of N-acetylcysteine and Silymarin in liver function improvement in patients with drug-induced liver injury Investigating the efficacy of simultaneous administration of N-acetylcysteine and Silymarin compared to N-acetylcysteine alone in liver function improvement in patients with drug-induced liver injury-clinical trial 2024-08-22 anticipated 130 Complete https://irct.ir/trial/78055 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 130 patients with drug-induced liver injury will be randomly assigned to 2 treatment groups using block randomization. Randomization will be performed in the STATA software using the ralloc command in blocks of sizes 6 and 8. Patients will be randomly allocated to the intervention and control groups (A and B). Based on the mentioned method, the allocation order of individuals to the intervention and control groups will be carried out randomly using STATA software. Using the complete command below, randomization of 130 samples into two groups in random blocks of sizes 6 and 8 will be performed. ralloc block size treat, nsubj(130) seed() sav(mytrial) idvar(study_ID) init(6) osize(2) noequal. 3 Drug-induced Liver injury. Intervention 1: Control group: The patients of this group will be treated with N-acetylcysteine (NAC) at a dose of 300mg/kg/day divided every 8 hours. This treatment will start when the patient is hospitalized and will continue until the patient is discharged from the hospital. The group will be monitored daily for clinical symptoms and liver profile tests, and the information obtained will be recorded in the checklists. Intervention 2: Intervention group: Patients in this group will be treated with Silymarin (Livergol) at a dose of 70-140 mg every 6 to 8 hours plus N-acetylcysteine (NAC) at a dose of 300 mg/kg/day divided every 8 hours. This treatment will start when the patient is hospitalized and will continue until the patient is discharged from the hospital. The patients of this group will be monitored daily for clinical symptoms and liver profile tests, and the information obtained will be recorded in the checklists. 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 I have not decided yet.
public Ava Doosti
Unit 20, No.7, before the 8th Alley, Hasan Abad St, East Ferdous Blvd
Tehran Iran (Islamic Republic of) 1481838964 +98 21 4400 7481 Ava.doosti1378@gmail.com Karaj University of Medical Sciences scientific Dr.Lida Shojaei
Alborz University of Medical Sciences, North Taleghani Blvd, Taleghani Sq.
Karaj Iran (Islamic Republic of) 3147734568 +98 26 3419 8000 l.shojaei52@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by Drug poisoning in the form of an increase in Liver enzymes AST, ALT more than 5 times the upper limit of normal, regardless of the presence of clinical symptoms, will be included in the study. All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by drug poisoning in the form of an increase in AST, ALT, and ALKP to twice the upper limit of normal along with total Bilirubin above 2 mg/dl will be included in the study. All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by drug poisoning in the form of an increase in AST, ALT to three times the upper limit of normal despite clinical symptoms (such as loss of appetite, fatigue, weakness and lethargy, nausea and vomiting, abdominal pain preferably epigastric and RUQ, itching, yellow skin or sclera, colorless stool or dark urine) will be included in the study. Since Liver damage caused by drug poisoning may not necessarily have significant and clear clinical symptoms, the preferred entry criterion will be the elevation of Liver enzymes, which will determine the importance of clinical symptoms in decision making. 12 years 80 years Both Patients with a history of underlying diseases of the Liver and Bile ducts (such as Alcoholic hepatitis, Autoimmune hepatitis, Non-alcoholic fatty liver disease (NAFLD), Viral hepatitis including Hepatitis B virus or Hepatitis C virus). T96 Sequelae of poisoning by drugs, medicaments and biological substances Treatment - Drugs Treatment - Drugs Control group: The patients of this group will be treated with N-acetylcysteine (NAC) at a dose of 300mg/kg/day divided every 8 hours. This treatment will start when the patient is hospitalized and will continue until the patient is discharged from the hospital. The group will be monitored daily for clinical symptoms and liver profile tests, and the information obtained will be recorded in the checklists. Intervention group: Patients in this group will be treated with Silymarin (Livergol) at a dose of 70-140 mg every 6 to 8 hours plus N-acetylcysteine (NAC) at a dose of 300 mg/kg/day divided every 8 hours. This treatment will start when the patient is hospitalized and will continue until the patient is discharged from the hospital. The patients of this group will be monitored daily for clinical symptoms and liver profile tests, and the information obtained will be recorded in the checklists. Serum levels of Aspartate aminotransferase(AST). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. Serum levels of Alanine aminotransferase(ALT). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. Serum levels of Alkaline phosphatase(ALP). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. Serum levels of Total Bilirubin. Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. Serum levels of Direct Bilirubin. Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. Clinical symptoms caused by hepatotoxicity (Loss of appetite, fatigue, weakness and lethargy, nausea and vomiting, abdominal pain preferably in the Epigastrium and RUQ, itching, yellowing of the skin or sclera, colorless stool or dark urine). Timepoint: At the beginning of hospitalization and then during daily visits of patient until discharge from the hospital. Method of measurement: By taking a history from the patient and asking the patient about the mentioned symptoms and during clinical examinations on daily visits. Karaj University of Medical Sciences Approved 2024-07-10 Ethics committee of Alborz University of Medical Sciences Alborz University of Medical sciences, North Taleghani Blvd, Taleghani Sq. Karaj Alborz Iran (Islamic Republic of)