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IRCT20200807048328N1 IRCT 2020-10-28 Arak University of Medical Sciences Effect of Curcumin on Liver enzymes and Liver T2*MRI in patients with Thalassemia. Evaluation of the effect of oral Curcumin on Liver enzymes and Liver T2*MRI in patients with major and intermediate Thalassemia at Amirkabir hospital in Arak in 2020. 2020-06-21 anticipated 60 Complete https://irct.ir/trial/51019 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The stochastic method of this study will be block type using 4 blocks (AABB, ABBA, BABA, etc.). For this purpose, the letter Intervention (I) is written on two cards and the letter Control (C) is written on two cards. To hide, the cards are placed in the envelope and turned upside down several times so that the order is not clear. Upon arrival of each participant, a card is selected for him and the selected card is discarded. This is also done for the next three patients to identify 4 people. Then, in the same way, randomization will be done for other groups of 4 to achieve the desired sample size. Then, after randomization and assigning the person to one of the groups, the necessary tests mentioned above are performed for him. The drug is then given to the person for 6 months as mentioned above and every month and after 6 months, tests are performed for him again. In addition, at the beginning of the project, informed written consent and demographic information such as age, sex, height, weight and body mass index will be completed, Blinding description: This study is a double-blind study. Participants will be blinded using the same appearance of curcumin and placebo, and patients have no idea which group they belong to. Also, the researcher who gives the drugs to the two groups will not be aware of the type of drug and the researcher will be blinded in this way. 3 Iron Overload in Beta Thalassaemia Major and Intermedia patients. Intervention 1: Intervention group: participants in the intervention group will be given the drug curcumin karen containing 95% turmeric extract. This drug will be given as a capsule in the amount of 500 mg twice a day, daily for 6 months. Intervention 2: Control group: a placebo will be given to participants in the control group. The appearance of this drug will be exactly the same as curcumin (we put it in similar pillboxes) and 2 capsules a day for up to 6 months will be given to patients in this group. 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 more informations.
public Arash Vahdati
Second floor, Research Deputy Building,  Complex of Payambare Azam, Basij Square (Sardasht)
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3645 research@arakmu.ac.ir Arak University of Medical Sciences scientific Arash Vahdati
Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht)
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3645 research@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age over 5 years old. Patients diagnosed with Thalassemia major and intermedia. Having conscious satisfaction. 5 years no limit Both Pregnancy. History of liver disease. Consumption of drugs affecting liver metabolism and liver enzymes and ferritin levels. History of turmeric allergy. Having bleeding disease. Taking anticoagulants. D56 Thalassemia Treatment - Drugs Placebo Intervention group: participants in the intervention group will be given the drug curcumin karen containing 95% turmeric extract. This drug will be given as a capsule in the amount of 500 mg twice a day, daily for 6 months. Control group: a placebo will be given to participants in the control group. The appearance of this drug will be exactly the same as curcumin (we put it in similar pillboxes) and 2 capsules a day for up to 6 months will be given to patients in this group. Aspartate aminotransferase. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. Alanine transaminase. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. Alkaline phosphatase. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. Total bilirubin. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. Direct bilirubin. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. Serum Ferritin. Timepoint: At the beginning of the study and every month for up to 6 months. Method of measurement: Patient blood sample. T2*-weighted imaging. Timepoint: At the beginning of the study and 6 months later. Method of measurement: Magnetic resonanse imaging machine. Arak University of Medical Sciences Approved 2020-10-05 Ethics committee of Arak University of Medical Sciences Second floor, Research Deputy Building, Complex of Payambare Azam, Basij Square (Sardasht) Arak Markazi Iran (Islamic Republic of)