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Study aim:
Evaluation of the effect of oral curcumin on liver enzymes and liver T2*MRI in patients with major and intermediate thalassemia
Design:
Clinical trials with control group, randomized assignment to intervention and control groups, double blind study, with a sample size of 80
Settings and conduct:
This clinical trial study will carry out in patients with major and intermediate thalassemia referred to Ali Asghar Children's Hospital.The patients will be coded according to the order of entry and randomly divided into two groups of intervention and the control group. The intervention group will receive the Curcumin tablet. The control group will receive the placebo . All subjects entering the trial will be checked in terms of the level of liver enzymes including bilirubin, ALT, AST, ALP and ferritin. Liver T2 * MRI will be performed at the beginning and end of the study. Patients will be monitored for 6 months by measuring their level of liver enzymes on a monthly basis and will be compared in two groups at the end of 6 months.
Participants/Inclusion and exclusion criteria:
Entry requirements: All patients with major and intermediate thalassemia. Exit conditions: Parental dissatisfaction; Renal failure; Hepatitis B; Hepatitis C; AIDS
Intervention groups:
The intervention group will receive curcumin oral tablet. The control group will receive placebo.
Main outcome variables:
Alanine Aminotransferase
Alkaline Phosphatase
Aspartate Aminotransferase
Total Bilirubin
Direct Bilirubin
ferritin
liver T2*MRI