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IRCT20111001007677N6 IRCT 2020-02-13 Kermanshah University of Medical Sciences Study on oral syrup of extract Cichorium intybus root on decreasing liver enzymes in thalassemia patients in Mohammad Kermanshahi hospital of Kermanshah city. Study on oral syrup of extract Cichorium intybus root on decreasing liver enzymes in thalassemia patients in Mohammad Kermanshahi hospital of Kermanshah city. 2020-01-20 anticipated 100 Complete https://irct.ir/trial/44797 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization and random assignment of people to two groups is done by generating random numbers using the random number table. That is, the participants in the study were divided into intervention and control groups by simple and individual randomization with the help of random number table. In this method, the person assigned to the first selected number (randomly) is placed in the intervention group and the person assigned to the next selected number (randomly) is assigned to the control group and this process until the end of assignment of people to two groups. Intervention and control continue, Blinding description: Participants in the study and the data analyzer are blind for drug or placebo administration. Medication and placebo had the same packaging, taste, volume, and color. 3 thalassemia disease. Intervention 1: Intervention group: Patients will receive chicory extract as a medicinal supplement. The amount of chicory extract will be evaluated based on the BMI of the patients. Gram will be administered in 5 ml of chicory extract. The chicory extract is manufactured and standardized by the Razi University School of Pharmacy. Intervention 2: Control group:Patients in the control group will receive placebo at the rate of twenty-eight milligrams per kilogram of body weight. The placebo will be developed and standardized by Razi University School of Pharmacy. 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 Adherence to study ethical standards
public Sevda Khashman
Mohammad Kermanshahi Hospital, Helal Ahmar Road, Kermanshah
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8208 dr.s.khashman@gmail.com Kermanshah University of Medical Sciences scientific Mohammadreza Golpayegani
Mohamad Kermanshahi Hospital, Helal Ahmar Road, Kermanshah
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8204 mrgolpayegani@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) major and intermediate thalassemic pations with abnormal AST and ALT 2 years no limit Both liver failure viral hepatitis ferritin level more than 3000 D56 Thalassemia Treatment - Drugs Placebo Intervention group: Patients will receive chicory extract as a medicinal supplement. The amount of chicory extract will be evaluated based on the BMI of the patients. Gram will be administered in 5 ml of chicory extract. The chicory extract is manufactured and standardized by the Razi University School of Pharmacy. Control group:Patients in the control group will receive placebo at the rate of twenty-eight milligrams per kilogram of body weight. The placebo will be developed and standardized by Razi University School of Pharmacy. Aspartate aminotransferase. Timepoint: At baseline, one and a half months later, three months later, six months later. Method of measurement: ELISA method and iranian science antibody kits. Alanin aminotransferase. Timepoint: At baseline, one and a half months later, three months later, six months later. Method of measurement: ELISA method and iranian science antibody kits. Kermanshah University of Medical Sciences Approved 2019-12-17 Ethics Committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)