Effects of grape seed extract on thalassemia major

Study of the synergistic effects of grape seed extract with deferasirox on oxidative stress, hemoglobin levels, blood coagulation, serum ferritin levels and inflammatory biomarkers in children with major thalassemia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180603039959N2

Enrollment

Registered

2020-10-05

Start date

2020-08-22

Completion date

Unknown

Last updated

2020-10-06

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

Conditions

Thalassemia major. Beta thalassemia

Interventions

Intervention 1: Intervention group: Patients are treated for 4 weeks with grape seed extract (made in Shari Pharmaceutical Industrial Company) 100 mg PO daily in combination with Deferasirox (made

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients affected by major thalassemia Iron chelators consumption for at least 2 years A history of iron chelator steady dose for the last 3 months Having serum ferritin level more than 1000 µg/L Patients with age limitation of 2 to 18 years old

Exclusion criteria

Exclusion criteria: Change in iron chelator therapy during the study (6 months)

Design outcomes

Primary

Measure	Time frame
Glutathion peroxidase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of glutathion peroxidase enzyme activity ZellBio kits are used.;Superoxide dismutase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of Superoxide dismutase enzyme activity ZellBio kits are used.;Catalase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of Catalase enzyme activity ZellBio kits are used.;TNF-alpha level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of TNF-alpha level IBL kit is used.;Malon dyaldehyde level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of malon dyaldehyde the Satho method is used.;Hemoglobin level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Hemoglobin level is measured by Complete blood count test.;Red blood cell count. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Red blood cell count is measured by Complete blood count test.;Serum ferritin level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum ferritin level is measured by serum ferritin level.;Serum aminotransferase. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum aminotransferase is measured by aspartate aminotransferase (AST) test and alanine aminotransferase (ALT) test.;Blood urea nitrogen level. Timepoint: At th	—

Measure

Time frame

Glutathion peroxidase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of glutathion peroxidase enzyme activity ZellBio kits are used.;Superoxide dismutase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of Superoxide dismutase enzyme activity ZellBio kits are used.;Catalase enzyme activity. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of Catalase enzyme activity ZellBio kits are used.;TNF-alpha level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of TNF-alpha level IBL kit is used.;Malon dyaldehyde level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: For measurement of malon dyaldehyde the Satho method is used.;Hemoglobin level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Hemoglobin level is measured by Complete blood count test.;Red blood cell count. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Red blood cell count is measured by Complete blood count test.;Serum ferritin level. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum ferritin level is measured by serum ferritin level.;Serum aminotransferase. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum aminotransferase is measured by aspartate aminotransferase (AST) test and alanine aminotransferase (ALT) test.;Blood urea nitrogen level. Timepoint: At th

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBijan Keikhaei dehdezi

Ahvaz University of Medical Sciences

keikhaeib@yahoo.com00980166173271

Outcome results

None listed

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