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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015010711392N2
Enrollment
100
Registered
2015-02-02
Start date
2012-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drug induced hypertransaminasemia. abnormal serum enzyme levels

Interventions

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
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

Sponsors

Vice-chancellor for research-Medical school of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Months to 13 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Asgarshirazi

School of Medicine,Tehran University of Medical Sciences

dr.m.asgarshirazi@gmail.com+98 21 6658 1596

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026