Protocol summary
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Study aim
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Study of oral Liverghol impact on enzymes of liver in patients with major thalassemia and intermedia thalassemia .
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Design
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Clinical trial with a control group with parallel groups, two-blind, randomized.
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Settings and conduct
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This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak on patients with thalassemia, also the study will also be two blinded in which patients and researcher will be blinded in study. This assessment is a clinical trial in Phase 3, the children who are diagnosed with thalassemia major and Intermedia 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.
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Participants/Inclusion and exclusion criteria
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Patients over 5 years of age with β-thalassemia major and intermedia 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.
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Intervention groups
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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.
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Main outcome variables
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Liver Enzymes Level
General information
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Reason for update
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Change the method from one blinded to two blinded
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150119020715N9
Registration date:
2019-01-17, 1397/10/27
Registration timing:
registered_while_recruiting
Last update:
2019-12-20, 1398/09/29
Update count:
1
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Registration date
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2019-01-17, 1397/10/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-22, 1397/06/31
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Expected recruitment end date
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2019-07-22, 1398/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of Oral Liverghol Impact on Liver Enzymes in Patients with Thalassemia Major and Intermedia
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Public title
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Evaluation Liverghol Impact on Liver Enzymes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients over 5 years of age with β-thalassemia Major and Intermedia 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
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Age
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From 5 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This means that patients in groups and researcher 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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-30, 1397/09/09
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Ethics committee reference number
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IR.ARAKMU.REC.1397.109
Health conditions studied
1
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Description of health condition studied
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Thalassemia Major and Intermedia
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ICD-10 code
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D56
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ICD-10 code description
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Thalassemia
Primary outcomes
1
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Description
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Liver Enzymes
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Timepoint
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Before treatment, with a month's interval in six month from starting treatment
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Method of measurement
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Blood tests
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: The same placebo take two times per day, for 6 months.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available