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Effect of Livergol in treatment of thalassemia major and intermedia

Evaluation the efficacy of Livergol(Sylimarin extract) on liver function of thalassemia major and intermedia patients: A triple-blinded, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220424054645N1
Enrollment
80
Registered
2022-05-18
Start date
2022-06-22
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Thalassemia. Thalassemia

Interventions

Intervention 1: Intervention group: In cases under 12 years of age take one tablet(70 mg)and over 12 years of age take two tablets(140 mg) of Livergol oral pills ,product of Goldaru pharmaceutical com

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Confirmed thalassemia major and intermedia cases with CBC and HB electerophoresis Patients without anaphylactoid reactions to any medication Patients with ALT rising more than two times of upper normal limit Consent to participate in trial Iron overload(serum ferritin of1000-5000ng/l) during 6 months before study Negative CRP

Exclusion criteria

Exclusion criteria: Hepatitis B or C virus infection HIV positive test Chronic kidney disease Thalassemia major patients with irreversible cirrhosis including 1-hyperglycemia 2-hyperalbuminemia 3-coagulopathy (INR> 1.5 and platelets <15000) Symptoms of increased portal vein pressure include ascites, esophageal varices, splenomegaly Research units have not tendency to continue the study

Design outcomes

Primary

MeasureTime frame
Ferritin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Blood tests.;ALT. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Blood tests.;AST. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Ghaeini Hesarooeyeh

Bandare-abbas University of Medical Sciences

zahraghaeini98@gmail.com+98 933 282 6058

Outcome results

None listed

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