]>
IRCT20220526055001N1 IRCT 2022-11-16 Kermanshah University of Medical Sciences Efficacy of chicory plant syrup on liver enzymes in patients with acute lymphoblastic leukemia Evaluation of the effect of oral chicory extract on liver enzymes in patients with acute lymphoblastic leukemia: A clinical trial 2022-09-14 anticipated 110 Complete https://irct.ir/trial/65651 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random method. 110 cards are selected and numbers from 1-110 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group, Blinding description: The current study is a double blind clinical trial study. The observer and statistician do not know about the allocation of people to the intervention and control groups. To blind the observer, a person outside the research team performs the liver tests on the patients and does not know the type of medicine that the patients receive. For the purpose of blinding the statistician, the coded data is provided to him for analysis. N/A Acute lymphoblastic leukemia. Intervention 1: The intervention group will receive 5 cc chicory plant extract (Produced by Razi University Pharmaceutical Department)in the form of syrup as a daily supplement for one week to one and up to 3 months based on the level of liver enzymes. Intervention 2: The control group will receive zinc sulfate syrup as a placebo daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Dr. Mohammad Reza Golpaygani
Hellal ahmar crossroad, Hosseinieh Andisheh Park
Kermanshah Iran (Islamic Republic of) 6714415333 +98 918 830 2455 sara.kooti@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Mohammad Reza Golpaygani
Hellal ahmar crossroad, Hosseinieh Andisheh Park
Kermanshah Iran (Islamic Republic of) 6714415333 +98 918 830 2455 sara.kooti@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Children with acute lymphoblastic leukemia (ALL) who have blood levels of liver enzymes more than 4-2 times normal are included in the study In the consent form, giving the participants the right to choose to participate or not to participate in the research and to keep the information confidential A written consent form from the child or their parents is the moral obligation of the researcher not to impose costs on the patients no limit 17 years Both In case of hepatitis and liver failure, they will be excluded from the study. C91.0 Acute lymphoblastic leukemia [ALL] Treatment - Drugs Placebo The intervention group will receive 5 cc chicory plant extract (Produced by Razi University Pharmaceutical Department)in the form of syrup as a daily supplement for one week to one and up to 3 months based on the level of liver enzymes. The control group will receive zinc sulfate syrup as a placebo daily. Level of ALT liver enzymes. Timepoint: The beginning of the study, one and a half months, three and six months after the end of the study. Method of measurement: blood test. Level of liver enzymes AST. Timepoint: The beginning of the study, one and a half months, three and six months after the end of the study. Method of measurement: blood test. Serum bilirubin level. Timepoint: The beginning of the study, one and a half months, three and six months after the end of the study. Method of measurement: blood test. Kermanshah University of Medical Sciences Approved 2022-04-24 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)