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

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

A randomized, blinded, controlled clinical trial of 60 patients, enrolled between August 2020 and March 2021, and followed for 2 months

A randomized, blinded controlled clinical trial of 60 children with thalassemia major who meets inclusion criteria without any of the exclusion criteria are enrolled in the study. The study is performed in hematology and oncology Specialty and sub-specialty shahid Baghaee 2 hospital. Patients are randomly stratified into 2 groups. The first group receives deferasirox 30 mg/Kg PO daily and the second group receives deferasirox 30 mg/Kg PO daily plus grape seed extract 100 mg PO daily. patients and major researcher are blinded via simulation of drug and placebo packages. Data is collected at the start of the study, after 2 weeks and 4 weeks of treatment.

Inclusion criteria: Patients affected by major thalassemia; Iron chelators consumption for at least 2 years; A history of iron chelators steady dose for the last 3 months; Having serum ferritin level more than 1000 μg/L Exclusion criteria: Change in iron chelator therapy during the study (6 months)

Control group receives deferasirox 30mg /Kg daily PO. Case group receives deferasirox 30 mg/Kg daily plus grape seed extract 100 mg daily PO.

Glutathione peroxidase, superoxide dismutase, malondialdehyde, Glutathione, Hemoglobin, red blood cell count, prothrombin time, partial thromboplastin time,international normalized ratio, Billirubin direct and indirect, aminotransferase enzymes, alkaline phosphatase, Ferritin level, catalase enzyme activity, tissue necrosis factor-α, serum Albumin

Randomization is simple. Randomization unit is individual. Randomization tool is sealed envelope. Concealment is performed through similar capsules containing drug and placebo. Random sequence generation is made by envelops shuffling.

In this double blind study, participants and the major researcher are kept blind to the study groups. Randomization tool is sealed envelope so that the major researcher is unaware of the envelope content delivered to the patients. Concealment is performed through similar capsules containing drug and placebo so that the participants are unaware of the prescribed drug .