Protective effects of silymarin on cardiac and hepatic side effects of chemotherapy drugs

Evaluating silymarin effects on cardiac and hepatic side effects of chemotherapy drug in children with acute lymphoblastic leukemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017071935175N1

Enrollment

Registered

2017-08-18

Start date

2015-05-22

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

Acute lymphoblastic leukemia. Acute lymphoblastic leukaemia [ALL]

Interventions

Intervention 1: Chemotherapy associated with Livergol Tablet (contaning 70 mg Silymarin ) 5mg/kg/day/PO/ in 2 divided doses/ half an hour before meal [Goldaru Pharma Com, Iran]. Intervention 2: Contr

Treatment - Drugs

Chemotherapy associated with Livergol Tablet (contaning 70 mg Silymarin ) 5mg/kg/day/PO/ in 2 divided doses/ half an hour before meal [Goldaru Pharma Com, Iran]

Control group: Routine care

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diagnosis of ALL based on bone marrow morphology and immunophenotype; Age 2-14 years; Therapy in maintenance phase of childhood ALL (at least 6 months); Exclusion criteria: Previous history of liver and heart disease; Take any other medicines except chemotherapy drug

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Liver enzymes: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Blood test.;Cardiac function. Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Echocardiography, measuring enzyme Creatine kinase- Muscle and Brain (CK-MB) and Lactate Dehydrogenase (LDH).;Coagulation testes: Prothrombin Time (PT), activeted Partial Tromboplastin Time (aPTT) and International Normal Ratio (INR). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Blood test.	—

Measure

Time frame

Liver enzymes: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Blood test.;Cardiac function. Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Echocardiography, measuring enzyme Creatine kinase- Muscle and Brain (CK-MB) and Lactate Dehydrogenase (LDH).;Coagulation testes: Prothrombin Time (PT), activeted Partial Tromboplastin Time (aPTT) and International Normal Ratio (INR). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Blood test.

—

Secondary

Measure	Time frame
Ejection Fraction (EF). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Ecocardiography.;Cardiac Systolic Function (SF). Timepoint: Before, 3 and 6 months after intervention. Method of measurement: Ecocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nahid Reisi

Isfahan University of Medical Sciences

reisi@med.mui.ac.ir+98 31 3235 0210

Outcome results

None listed

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