Effect of Silymarin on Serum Ferritin and Iron Level in ß-thalassemia Patients

Evaluation the Effect of Silymarin on Serum Ferritin and Iron Level in Comparison with Placebo in ß-thalassemia Patients undergoing Iron Chelation Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015101211819N2

Enrollment

Registered

2016-04-10

Start date

2014-12-22

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

Thalassaemia. Beta thalassaemia

Interventions

Intervention 1: Patients in the intervention group received 420 milligrams of silymarin tablets, three times per day. Intervention 2: Patients in the control group received placebo tablets, three time

Treatment - Drugs

Placebo

Patients in the intervention group received 420 milligrams of silymarin tablets, three times per day.

Patients in the control group received placebo tablets, three times per day.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with beta thalassemia major; History of iron chelation therapy for at least 2 years; Having relatively constant average dose of iron chelation during 3 months ago; Ferritin up to 1000 µg/L Exclusion criteria: Change therapeutic regimen with iron chelation during the study (6 months)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum Iron Level. Timepoint: 1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks). Method of measurement: Serum Iron was measured by spectrophotometry.;Serum Ferritin Level. Timepoint: 1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks). Method of measurement: Serum ferritin was measured by ELISA test.	—

Measure

Time frame

Serum Iron Level. Timepoint: 1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks). Method of measurement: Serum Iron was measured by spectrophotometry.;Serum Ferritin Level. Timepoint: 1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks). Method of measurement: Serum ferritin was measured by ELISA test.

—

Secondary

Measure	Time frame
Incidence of adverse drug reactions. Timepoint: 1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks). Method of measurement: Data collection form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Darvishi Khezri

7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran

Hadidarvishi87@yahoo.com+98 11 3334 7837

Outcome results

None listed

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