]>
IRCT20190202042583N4 IRCT 2023-11-06 Mazandaran University of Medical Sciences Evaluation of the effect of L-carnitine on the prevention of drug induced hepatitis Evaluation of the effect of L-carnitine on the prevention of PEG-Asparaginase-induced hepatitis in patients with acute lymphoblastic leukemia 2023-03-21 anticipated 38 Complete https://irct.ir/trial/70964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: We divide each client into two groups using a random table. This table is a set of numbers. Consider the numbers 1 to 19 for intervention A and the numbers 20 to 38 for control B (for both size groups larger and smaller than 4 cm). Then we touch one of the numbers and move into one of the predetermined directions and record the numbers and assign them to one of the groups. In this way, patients are divided completely randomly, Blinding description: On the pharmaceutical form and the main drug, which is prepared by the project's pharmaceutical team, stickers containing Latin numbers and letters are attached, and these numbers and letters are recorded secretly. Medicines and placebos are delivered to the department. When it is necessary to prescribe medicine, with the coordination of the project executive resident (who is not aware of the type of medicine or placebo), the medicine is given to the patient randomly. The tag number is recorded in the data collection form. In the studies, the type of preparation of the drug or placebo is determined based on the equality of registration of labels and forms. The resident who implements the plan and the patient and the patient's parents will not have any information about the contents of the plan. 3 Acute Lymphoblastic Leukemia. Intervention 1: Intervention group: Before entering the induction phase, preliminary tests are taken from each patient according to the protocol, which are recorded daily until the fourteenth day after receiving asparaginase. L-carnitine is administered orally at a dose of 50 mg/kg per day every 12 hours. The patient's changes are recorded daily by the clinical caregiver, and if hepatitis occurs and the level of liver enzymes increases to double the normal state, the study is stopped and started ursodeoxycolic for patient treatment. Intervention 2: Control group: Before entering the induction phase, initial tests are taken from each patient according to the protocol, which are recorded daily until the 14th day after receiving Asparaginase. From the second day of hospitalization to the 14th day after receiving asparaginase, placebo is given every 12 hours. The placebo will be prepared by the pharmacist of the plan, which will be similar in shape, size, color and taste to the drug. 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 the results will be published later.
public Mohammad NaderiSorki
Bu Ali Sina Hospital, Pasdaran Bulv.
sari Iran (Islamic Republic of) 4815838477 +98 11 3334 7837 dr.naderisorki@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Nadeisorki
Bu Ali Sina Hospital, Pasdaran Bulv.
sari Iran (Islamic Republic of) 4815838477 +98 11 3334 7837 dr.naderisorki@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) getting acute lymphoblastic leukemia normal enzyme levels at the beginning of the study 1 month 18 years Both underlying liver disease underlying metabolic disease involving the liver (galactosemia-tyrosinemia-...) Viral hepatitis Use of hepatotoxic drugs Elevation of bilirubin or liver transaminases above normal values before the start of the study Contraindication or allergy to L-carnitine C91.0 Acute lymphoblastic leukemia [ALL] Prevention Placebo Intervention group: Before entering the induction phase, preliminary tests are taken from each patient according to the protocol, which are recorded daily until the fourteenth day after receiving asparaginase. L-carnitine is administered orally at a dose of 50 mg/kg per day every 12 hours. The patient's changes are recorded daily by the clinical caregiver, and if hepatitis occurs and the level of liver enzymes increases to double the normal state, the study is stopped and started ursodeoxycolic for patient treatment. Control group: Before entering the induction phase, initial tests are taken from each patient according to the protocol, which are recorded daily until the 14th day after receiving Asparaginase. From the second day of hospitalization to the 14th day after receiving asparaginase, placebo is given every 12 hours. The placebo will be prepared by the pharmacist of the plan, which will be similar in shape, size, color and taste to the drug. Drug induced Hepatitis. Timepoint: before receiving the drug to 14 days after receiving PEG-Asparaginase. Method of measurement: by the clinical supervisor accompanying the plan and according to the criteria of the World Health Organization. Dr.Mohammad Naderisorki Approved 2023-01-04 Ethics committee of Mazandaran University of Medical Sciences Central Headquarters of Mazandaran University of Medical Sciences, at the beginning of Valiasr Highway sari Mazandaran Iran (Islamic Republic of)