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IRCT20080901001165N69 IRCT 2022-09-16 Bonyan Salamat Kasra pharmaceutical company Evaluation of the efficacy and safety of L-carnitine in improving liver function in liver injury Evaluation of the efficacy and safety of L-carnitine in improving liver function in liver injury 2022-09-23 anticipated 100 Complete https://irct.ir/trial/63017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Block Randomization method is used to randomize the patients. For randomization, we visited www.sealedenvelope.com, then the randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention, Blinding description: The placebo looks the same as the original drug, provided by the drug company. In this study, the prescribing physician, patient, therapeutic team, and statistical analyzer are unaware of the type of intervention (intervention/placebo). 3 Diseases of liver. Intervention 1: Intervention group: L-carnitine oral vial containing 2 grams of L-carnitine drug, 1 orally every 12 hours, for 5 days. This drug is produced by the Bonyan Salamat Kasari pharmaceutical company. Intervention 2: Control group: oral vial placebo 2gr, every 12 hours one oral vial, for 5 days. 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 data release schedule is still unclear
public parisa kianpour
16 Azar St., Enghelab Sq., Tehran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 64120 ‏Parisa_kianpour@yahoo.com Tehran University of Medical Sciences scientific Yunes Panahi
Mollasadra Street, Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8821 1524 yunespanahi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Have read and signed a written informed consent to participate in the study Age between 18-90 years old; The patient's Child-Pugh score is category B or C; 18 years 90 years Both Pregnancy; Breastfeeding; Participate in another clinical trial at the same time; History of previous allergies to any of the components of the drug; K76.9 Liver disease, unspecified Treatment - Drugs Placebo Intervention group: L-carnitine oral vial containing 2 grams of L-carnitine drug, 1 orally every 12 hours, for 5 days. This drug is produced by the Bonyan Salamat Kasari pharmaceutical company. Control group: oral vial placebo 2gr, every 12 hours one oral vial, for 5 days AST serum level. Timepoint: Before and after intervention. Method of measurement: Blood sample. ALT serum level. Timepoint: Before and after intervention. Method of measurement: Blood sample. Bilirubin serum level. Timepoint: Before and after the intervention. Method of measurement: Blood sample. Child-Pugh score. Timepoint: Before and after the intervention. Method of measurement: Child-Pugh score classification. Bagheiat-allah University of Medical Sciences Bonyan Salamat Kasra pharmaceutical company Bagheiat-allah University of Medical Sciences Approved 2022-03-12 Baqiyatallah Hospital Baqiyatallah Hospital, Sheykh-e-Baha'ee, Sare Mollasadra Tehran Tehran Iran (Islamic Republic of)