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IRCT20191010045050N1 IRCT 2020-01-05 Arak University of Medical Sciences Evaluation of the effect of oral prolive on liver function in patients with major and intermediate thalassemia Evaluation of the effect of oral proliveon liver function in patients with major and intermediate thalassemia 2019-12-01 anticipated 40 Complete https://irct.ir/trial/43003 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block Randomization Unit: Individual Randomization Tool: Envelope Method How to Build a Random Sequence: Using www.randomization.com Explanation of concealment: Using non-transparent sealed envelopes with a random sequence, Blinding description: Only the researcher in this study will be aware of the study groups while the patients will be not aware of the type of drug being used. Also, the intern responsible for filling the checklists will be not aware of the type of medication consumed, and only will know the groups based on A and B and will fill out the checklists accordingly. 3 Major and intermedia thallassemia. Intervention 1: Intervention group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients with age under 12 will receive half tablet and patients over 12 years will receive one tablet (275 mg) of oral Prolio twice daily (every 12 hours) and repeat tests up to 6 months each months. Intervention 2: Control group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients will receive two placebo tablet twice daily (every 12 hours) and repeat tests up to 6 months each month. 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 I haven't decided yet
public Azam Ebrahimi
91 Alley - Emam Khomeini Street
Esfahan Iran (Islamic Republic of) 8139949551 +98 86 3312 7359 azame7733@gmail.com Arak University of Medical Sciences scientific Azam Ebrahimi
Alley 91 - Emam khomeini street
Esfahan Iran (Islamic Republic of) 8139949551 +98 86 3312 7359 www.azame7733@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with beta thalassemia major and intermedia over 5 years 5 years 18 years Both Patients not willing to participate in the study Malignancy Liver dysfunction D77 Other disorders of blood and blood-forming organs in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients with age under 12 will receive half tablet and patients over 12 years will receive one tablet (275 mg) of oral Prolio twice daily (every 12 hours) and repeat tests up to 6 months each months. Control group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients will receive two placebo tablet twice daily (every 12 hours) and repeat tests up to 6 months each month. Liver enzyme. Timepoint: Before the intervention and after, every one month to six months. Method of measurement: Laboratory. Total Billirubin and Total protein. Timepoint: Before the intervention and after, every one month to six months. Method of measurement: Laboratory. Arak University of Medical Sciences Approved 2019-08-04 Ethics Commitee of Arak University of Medica sciences Arak University of Medica sciences ,Basij square , Sardasht Arak Markazi Iran (Islamic Republic of)