Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

NCT ID: NCT01752153

Last Updated: 2012-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-09-30

Brief Summary

A wide spectrum of immune abnormalities has been described by numerous studies involving β-thalassemic patients with multiple transfusions. The abnormalities observed are both quantitative and functional, and concern several components of the immune response. Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert multiple biological effects, including antioxidant and free radical scavenging abilities. Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn), have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as hepatoprotective agents. Silymarin is already being used clinically for treatment of liver diseases.It is considered safe and well-tolerated, with reported adverse events similar to placebo. Several studies have also reported immunomodulatory actions of silymarin. It increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro treatment of peripheral blood mononuclear cells with silymarin causes restoration of the thiol status and increases in T cell proliferation and activation. Because reactive oxygen species and iron overload play important roles in the pathophysiology of thalassemia, silymarin may be an effective therapy due to its antioxidant, immunomodulatory, cytoprotective and iron chelating activities. The present study designed to investigate the therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a well-known and prevalent disease in Iran, which is associated with oxidative stress, iron overload and immune abnormalities.

Conditions

Immune Abnormalities

Keywords

Focus; immunomodulatory effect; of silymarin; on cell mediated immunity; Beta-Thalassemia; major patients.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silymarin (Legalon)

Patients who were unable or unwilling to use desferrioxamine or had stopped desferrioxamine treatment for at least 6 months, were received only silymarin.

Group Type: EXPERIMENTAL

Silymarin (Legalon)

Intervention Type: DRUG

Combined therapy (Deaferrioxamine+Silymarin (Legalon)

In combined therapy group, patients continued desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy) was added to desferrioxamine regimen at the dose of 140 mg, taken orally, three times a day, 7 days a week.

Group Type: EXPERIMENTAL

Desferrioxamine, Legalon® (Silymarin)

Intervention Type: DRUG

Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)

Interventions

Desferrioxamine, Legalon® (Silymarin)

Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)

Intervention Type: DRUG

Silymarin (Legalon)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Homozygous beta-thalassemia major
• Regularly blood transfusion
• Iron chelation therapy with subcutaneous desferrioxamine (DFO)40.0 mg/Kg/day for 5-7 days/week

Exclusion Criteria

• Chronic hepatitis B infection
• Active hepatitis C infection
• A history of a positive HIV test
• Chronic renal or heart failure
• Iron chelation therapy with deferiprone
• Pregnancy
• Gastrointestinal conditions preventing absorption of an oral medication o
• noncompliance with prescribed therapy

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Marjan Gharagozloo

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra Amirghofran, PhD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Locations

Department of Immunology, School of Medicine, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

1929

Identifier Type: -

Identifier Source: org_study_id