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Evaluation the efficacy of Livergol(Sylimarin extract) on liver function of thalassemia major and intermedia patients: A triple-blinded, randomized, placebo-controlled trial

Protocol summary

Study aim
This study aims to investigate the effect of Sylimarin extract on liver function in patients with major thalassemia and intermedia thalassemia
Design
Concealed, randomized, triple blinded, phase 3 controlled clinical trial with two arm parallel group design of 80 patients, using the placebo in the control group.
Settings and conduct
This study will be performed in Abureyhan Specific Diseases Center in Bandar Abbas city. Patients enter the study after obtaining written consent. Patients are randomly assigned to one of the intervention or control groups with the placebo. Moreover, patients,care provider and investigators will not know which group they belong to. (tripple blinded)
Participants/Inclusion and exclusion criteria
Confirmed thalassemia major and intermedia cases by a specialist physician who have ALT > 2 times of upper normal limit ,iron overload (serum ferritin of 1000-5000ng/l) during 6 months before the study,negative CRP and signs the written consent of the study will be included in the study. Patients will be excluded from the study if they have a history of hepatitis B and C virus infection,HIV positive test,chronic kidney disease,irreversible cirrhosis,symptoms of portal vein hypertension or refuse to participate in the study.
Intervention groups
In the intervention group, people aged under12 years, 70 mg(one tablet)and over 12 years of age, 140 mg(two tablets) of Livergol for three times per day, in the control group, the same placebo is used three times per day.
Main outcome variables
Aspartate aminotransferase (AST) , alanine aminotransferase (ALT) and ferritin levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220424054645N1
Registration date: 2022-05-18, 1401/02/28
Registration timing: prospective

Last update: 2022-05-18, 1401/02/28
Update count: 0
Registration date
2022-05-18, 1401/02/28
Registrant information
Name
Zahra Ghaeini Hesarooeyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0370
Email address
z.ghaeeni@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Livergol(Sylimarin extract) on liver function of thalassemia major and intermedia patients: A triple-blinded, randomized, placebo-controlled trial
Public title
Effect of Livergol in treatment of thalassemia major and intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed thalassemia major and intermedia cases with CBC and HB electerophoresis Patients without anaphylactoid reactions to any medication Patients with ALT rising more than two times of upper normal limit Consent to participate in trial Iron overload(serum ferritin of1000-5000ng/l) during 6 months before study Negative CRP
Exclusion criteria:
Hepatitis B or C virus infection HIV positive test Chronic kidney disease Thalassemia major patients with irreversible cirrhosis including 1-hyperglycemia 2-hyperalbuminemia 3-coagulopathy (INR> 1.5 and platelets <15000) Symptoms of increased portal vein pressure include ascites, esophageal varices, splenomegaly Research units have not tendency to continue the study
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple,Block
Blinding (investigator's opinion)
Triple blinded
Blinding description
All participants are aware of participating in this study and enter the study with their consent.The participant , care provider and investigators do not know which box contains placebo tablets and which contains Livergol tablets.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hormozgan universuty of medical sciences
Street address
Clinical Research Development Center of Children's Hospital, Hormozgan University of Medical Sciences, Bandar Abbas,Hormozgan Province
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.HUMS.REC.1401.024

Health conditions studied

1

Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia

Primary outcomes

1

Description
Ferritin
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Blood tests

2

Description
ALT
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Blood tests

3

Description
AST
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In cases under 12 years of age take one tablet(70 mg)and over 12 years of age take two tablets(140 mg) of Livergol oral pills ,product of Goldaru pharmaceutical company, three times per day, for 3 months.
Category
Treatment - Drugs

2

Description
Control group: The same placebo ,product of pharmaceutical company,take three times per day, for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Abureyhan Specific Diseases Center
Full name of responsible person
Dr.Amir Hesabi
Street address
Educational,Research andTherapeutic Center of Children's Hospital, Northern Golshahr,Imam Khomeini Boulevard, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7915879154
Phone
+98 76 3366 6240
Email
amir.hesabi695@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teamur Aghamolaei
Street address
Children's Hospital,Northern Golshahr,Imam Khomeini Boulevard,Bandar Abbas,Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3366 6240
Email
research@hums.ac.ir
Web page address
https://resv.hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Zahra Ghaeini Hesarooeyeh
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 933 282 6058
Email
zahraghaeini98@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Amir Hesabi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7915879154
Phone
+98 76 3366 6240
Email
amir.hesabi695@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Zahra Ghaeini Hesarooeyeh
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 933 282 6058
Email
zahraghaeini98@gmail.com

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
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