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IRCT20221211056777N2 IRCT 2023-08-06 Shahre-kord University of Medical Sciences The effect of coenzyme Q10 supplement on Prevention of hepatotoxicity in patients with major β-thalassemia The effect of coenzyme Q10 supplement on Prevention of hepatotoxicity Caused by iron-overload in patients with major β-thalassemia referred to Hajar Hospital 2023-03-02 anticipated 50 Complete https://irct.ir/trial/68464 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 3 Thalassemia. 50 individuals with major thalassemia will be selected. Laboratory parameters (ALT, AST, HB, Ferritin, ESR, CRP, TIBC, LDH) will be examined initially and recorded along with demographic information in a checklist made by the researcher. Along with standard treatment (iron chelators such as deferoxamine, deferasirox, etc) they will also receive a daily dose of 100mg of Co-enzyme Q10 tablets (Golden Life) for eight weeks. After the eight weeks of medication, the parameters will be examined again.. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address miladnami75@gmail.com or the contact number 00989117640474 How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Milad Nami
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Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 miladnami75@gmail.com Shahre-kord University of Medical Sciences scientific Kiavash Fekri
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Shahrekord Iran (Islamic Republic of) 8816754633 0098383222116 k.fekri@muk.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients with thalassemia major Patients with thalassemia major with elevated liver enzymes Patients with thalassemia major with elevated inflammation markers no limit no limit Both Patients with active viral hepatitis Hepatotoxic drugs consumption Hypersplenism D56.1 Beta thalassemia Treatment - Drugs 50 individuals with major thalassemia will be selected. Laboratory parameters (ALT, AST, HB, Ferritin, ESR, CRP, TIBC, LDH) will be examined initially and recorded along with demographic information in a checklist made by the researcher. Along with standard treatment (iron chelators such as deferoxamine, deferasirox, etc) they will also receive a daily dose of 100mg of Co-enzyme Q10 tablets (Golden Life) for eight weeks. After the eight weeks of medication, the parameters will be examined again. Level of aspartate aminotransferase (AST) in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Level of alanine transaminase (ALT) in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Level of hemoglobin (Hb) in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Level of ferritin in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Measuring erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Level of C-reactive protein (Crp) in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Measuring Total iron binding capacity (TIBC). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Level of lactate dehydrogenase (LDH) in blood. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit. Shahre-kord University of Medical Sciences Approved 2022-10-04 Ethics Committee of Shahrekord University of Medical Sciences Kashani street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)