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IRCT2015010711392N2 IRCT 2015-02-02 Vice-chancellor for research-Medical school of Tehran University of Medical Sciences Comparison between Ursodeoxy cholic acid, silymarin and vitamin E in Anticonvulsive drugs induced hypertransaminasemia Comparison between efficacy and adverse effects of Ursodeoxy cholic acid, silymarin and vitamin E and placebo (Folic acid) in Anticonvulsive drugs induced hypertransaminasemia in 4 months to 13 years old patients 2012-06-21 anticipated 100 Complete https://irct.ir/trial/11653 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A drug induced hypertransaminasemia. Intervention 1: prescription of Folic acid as placebo in dose of 1mg/day in drug-induced hypertransaminasemia. Intervention 2: prescription of Ursodeoxy cholic acid in dose of 10mg/kg/day in drug induced hypertransaminasemia. Intervention 3: prescription of Silymarin in dose of 5mg/kg/day for anticonvulsive induced hypertransaminasemia. Intervention 4: prescription of Vitamin E in dose of 1mg or IU/kg/day up to 50mg/day for drug induced hypertransaminasemia.
public Masoumeh Asgarshirazi
Pediatrics ward, Valiasr Hospital, Imam Khomeini Hospital complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1596 dr.m.asgarshirazi@gmail.com School of Medicine,Tehran University of Medical Sciences scientific Masoumeh Asgarshirazi
Pediatrics ward, Valiasr Hospital, Imam Khomeini Hospital complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1596 dr.m.asgarshirazi@gmail.com School of Medicine, Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with age between 4 months to 13 years in pediatric neurology ward and clinic of Valiasr hospital with anticonvulsive induced hypertransaminasemia after rule out of common causes of hepatitis such as viral, autoimmune, metabolic and after rule out of anatomical defects have been included. Any patient without parents consent was excluded and any patient with spontaneous decline in transaminases were excluded too. 4 months 13 years Both R74.0 abnormal serum enzyme levels Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs prescription of Folic acid as placebo in dose of 1mg/day in drug-induced hypertransaminasemia prescription of Ursodeoxy cholic acid in dose of 10mg/kg/day in drug induced hypertransaminasemia prescription of Silymarin in dose of 5mg/kg/day for anticonvulsive induced hypertransaminasemia prescription of Vitamin E in dose of 1mg or IU/kg/day up to 50mg/day for drug induced hypertransaminasemia Transaminases levels. Timepoint: one month after intervention and one month after cessation of it. Method of measurement: serum transaminases with one standard kit and in International Unite per litre. No rebound elevation of serum transaminases after cessation of intervention. Timepoint: one month after intervention cessation. Method of measurement: with standard lab kit and in International Unite per litre. Vice-chancellor for research-Medical school of Tehran University of Medical Sciences Approved 2012-06-20 Research Deputy of Tehran University of Medical Sciences Poursina street, Keshavarz Blvd.,Tehran Tehran Iran (Islamic Republic of)