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IRCT20180603039959N2 IRCT 2020-10-05 Ahvaz University of Medical Sciences 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 2020-08-22 anticipated 60 Complete https://irct.ir/trial/49361 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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 . 2 Thalassemia major. 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 in Exir Pharmaceutical Industrial Company) 30 mg/Kg PO daily. Intervention 2: Control group: Patients are treated for 4 weeks with Deferasirox (made in Exir Pharmaceutical Industrial Company) 30 mg/Kg PO daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Bijan Keikhaei dehdezi
golestan Ave,. Shahid Baghaee sq., Shahid Baghaee 2 hospital
Ahvaz Iran (Islamic Republic of) 6138933333 00980166173271 keikhaeib@yahoo.com Ahvaz University of Medical Sciences scientific Bijan Keikhaei dehdezi
Golestan Ave., Shahid Baghaee sq., Shahid baghaee 2 hospital
Ahvaz Iran (Islamic Republic of) 6138933333 +98 916 617 3271 keikhaeib@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 2 years 18 years Both Change in iron chelator therapy during the study (6 months) D56.1 Beta thalassemia Treatment - Other Treatment - Other 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 in Exir Pharmaceutical Industrial Company) 30 mg/Kg PO daily. Control group: Patients are treated for 4 weeks with Deferasirox (made in Exir Pharmaceutical Industrial Company) 30 mg/Kg PO daily. 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 the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum blood urea nitrogen level is measured by Blood urea nitrogen (BUN) test. Serum creatinine. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Serum creatinine level is measured by creatinine test. Prothrombin time. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Prothrombin time is measured by Prothrombin time (PT) test. Partial thromboplastin time. Timepoint: At the beginning of the study, after 2 weeks of treatment, after 4 weeks of treatment. Method of measurement: Partial thromboplastin time is measured by Partial thromboplastin time (PTT) test. Ahvaz University of Medical Sciences Approved 2020-06-29 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Ave., Shahid Baghaee sq., Shahid Baghaee 2 hospital. Ahvaz Khouzestan Iran (Islamic Republic of)