Evaluation of the effect of oral livergol on liver enzymes in patients with Leukemia in the Preservative Phase
Design
Clinical trial with a control group with parallel groups, one-blind, randomized.
Settings and conduct
This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak on patients with leukemia, also the study will also be single blinded in which patients will be blinded in study. This assessment is a clinical trial in Phase 3, the children who are diagnosed with leukemia in the preservative phase and approved by a specialist physician are considered as a study group. In this study, 40 children who have entered the criteria are selected. Patients are categorized based on blocked randomization method, 20 children in the intervention group (recipient of the livergol) and 20 children in the control group (recipient of the placebo). Accordingly, the status of liver enzymes is evaluated initially and then monthly for 6 months after starting treatment.
Participants/Inclusion and exclusion criteria
Patients over 5 years of age with leukemia in the preservative phase referred to Amir Kabir hospital in Arak, with informed consent in the study, impaired hepatic enzymes (AST And ALT greater than 60), total cholesterol above 200, total bilirubin more than 2, and Gamma glutamyl transpeptidase more than 60 are enrolled in the study, also patients with other blood diseases and liver diseases such as HBV, HCV and HIV excluded from the study.
Intervention groups
In the intervention group, people aged below 12 years of age, 70 mg and over 12 years of age, 140 mg of livergol tablets for two times per day, in the control group, the same placebo is used two per day.
Main outcome variables
Liver Enzymes Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020715N10
Registration date:2019-06-16, 1398/03/26
Registration timing:prospective
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral livergol on liver enzymes in patients with Leukemia in the Preservative Phase
Public title
Effect of oral livergol on liver enzymes in patients with Leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 5 years of age with leukemia in the preservative phase referring to Amir Kabir hospital in Arak
Informed consent of the participants in the study
Disrupted liver enzymes (AST and ALT greater than 60).
Total cholesterol above 200
Total bilirubin equal to or greater than 2
GGT more than 60
Exclusion criteria:
With other blood diseases and liver diseases such as HBV, HCV and HIV
Age
From 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging, two drugs are similar in color, two drugs are similar in taste and odor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.ARAKMU.REC.1397.292
Health conditions studied
1
Description of health condition studied
Leukemia in the Preservative Phase
ICD-10 code
C95.9
ICD-10 code description
Leukemia, unspecified
Primary outcomes
1
Description
Liver Enzymes
Timepoint
Before treatment, with a month's interval in six month from starting treatment
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In cases under 12 years of age take 70 mg and over 12 years of age take 140 mg of Liverghol oral pills two times per day, for 6 months.
Category
Treatment - Drugs
2
Description
Control group: The same placebo take two times per day, for 6 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir hospital
Full name of responsible person
Roghaie Rahimi Afzal
Street address
Amir Kabir hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
mahmoodrezaie069@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dr.eghbali@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Blood specialist and oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Amir-Kabir Hospital, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+33 135075
Email
dr.eghbali@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Associate Professor of Pediatric oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Amir-Kabir Hospital, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+33 135075
Email
dr.eghbali@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Associate Professor of Pediatric oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Amir Kabir Hospital, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dr.eghbali@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available