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Protocol summary
Clinical trial with a control group with parallel groups, one-blind, randomized.
Clinical trial with a control group with parallel groups, two-blind, randomized.
Clinical trial with a control group with parallel groups, onetwo-blind, randomized.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور و تصادفی شده می باشد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دوسویه کور و تصادفی شده می باشد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویهدوسویه کور و تصادفی شده می باشد.
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 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 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.
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.
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 singletwo 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.
این مطالعه به صورت کارازمایی بالینی در کلینیک اطفال بیمارستان امیرکبیر اراک و بر روی بیماران مبتلا به تالاسمی انجام می شود، همچنین مطالعه به صورت یک سو کور خواهد بود که در آن برای بیماران انجام مطالعه کور خواهد شد. این ارزیابی یک کارآزمایی بالینی در فاز 3 می باشد، کودکانی که با تشخیص تالاسمی ماژور و اینترمدیا هستند و توسط پزشک متخصص تایید شده اند، به عنوان گروه مطالعاتی در نظر گرفته می شوند، در این مطالعه 40 کودکی که معیارهای ورود را دارند انتخاب می شوند. بیماران به صورت تخصیص تصادفی و با روش بلاکی در دو دسته قرار می گیرند، 20 کودک در گروه مداخله و دریافت کننده لیورگول و 20 کودک در گروه شاهد و دریافت کننده دارونما قرار می گیرند. بر این اساس در ابتدا و سپس هر ماه به مدت 6 ماه بعد از شروع درمان وضعیت انزیم های کبدی به روش الایزا ارزیابی می شود.
این مطالعه به صورت کارازمایی بالینی در کلینیک اطفال بیمارستان امیرکبیر اراک و بر روی بیماران مبتلا به تالاسمی انجام می شود، همچنین مطالعه به صورت دو سو کور خواهد بود که در آن برای بیماران و محقق انجام مطالعه کور خواهد شد. این ارزیابی یک کارآزمایی بالینی در فاز 3 می باشد، کودکانی که با تشخیص تالاسمی ماژور و اینترمدیا هستند و توسط پزشک متخصص تایید شده اند، به عنوان گروه مطالعاتی در نظر گرفته می شوند، در این مطالعه 40 کودکی که معیارهای ورود را دارند انتخاب می شوند. بیماران به صورت تخصیص تصادفی و با روش بلاکی در دو دسته قرار می گیرند، 20 کودک در گروه مداخله و دریافت کننده لیورگول و 20 کودک در گروه شاهد و دریافت کننده دارونما قرار می گیرند. بر این اساس در ابتدا و سپس هر ماه به مدت 6 ماه بعد از شروع درمان وضعیت انزیم های کبدی به روش الایزا ارزیابی می شود.
این مطالعه به صورت کارازمایی بالینی در کلینیک اطفال بیمارستان امیرکبیر اراک و بر روی بیماران مبتلا به تالاسمی انجام می شود، همچنین مطالعه به صورت یکدو سو کور خواهد بود که در آن برای بیماران و محقق انجام مطالعه کور خواهد شد. این ارزیابی یک کارآزمایی بالینی در فاز 3 می باشد، کودکانی که با تشخیص تالاسمی ماژور و اینترمدیا هستند و توسط پزشک متخصص تایید شده اند، به عنوان گروه مطالعاتی در نظر گرفته می شوند، در این مطالعه 40 کودکی که معیارهای ورود را دارند انتخاب می شوند. بیماران به صورت تخصیص تصادفی و با روش بلاکی در دو دسته قرار می گیرند، 20 کودک در گروه مداخله و دریافت کننده لیورگول و 20 کودک در گروه شاهد و دریافت کننده دارونما قرار می گیرند. بر این اساس در ابتدا و سپس هر ماه به مدت 6 ماه بعد از شروع درمان وضعیت انزیم های کبدی به روش الایزا ارزیابی می شود.
General information
Single blinded
Double blinded
singldoubl
1
1
empty
Change the method from one blinded to two blinded
Change the method from one blinded to two blinded
empty
تغییر روش اجرا از یک سویه کور به دوسویه کور
تغییر روش اجرا از یک سویه کور به دوسویه کور
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.
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.
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.
به این صورت که بیماران در دو گروه از داروی استفاده شده اطلاعی ندارند و بسته بندی دارو ها به صورت مشابه انجام می شود، دو دارو از نظر رنگ مشابه هستند، دو دارو از نظر طعم و بو مشابه می باشند.
به این صورت که بیماران در دو گروه و محقق از داروی استفاده شده اطلاعی ندارند و بسته بندی دارو ها به صورت مشابه انجام می شود، دو دارو از نظر رنگ مشابه هستند، دو دارو از نظر طعم و بو مشابه می باشند.
به این صورت که بیماران در دو گروه و محقق از داروی استفاده شده اطلاعی ندارند و بسته بندی دارو ها به صورت مشابه انجام می شود، دو دارو از نظر رنگ مشابه هستند، دو دارو از نظر طعم و بو مشابه می باشند.
Recruitment centers
#1
Name of recruitment center - English: Department of Pediatrics, Amir Kabir Hospital
Name of recruitment center - Persian: بخش اطفال، بیمارستان امیرکبیر اراک
Full name of responsible person - English: Roghaie Rahimi Afzal
Full name of responsible person - Persian: رقیه رحیمی افضل
Street address - English: 3819693345, Amir Kabir Hospital, Basij Square, Arak.
Street address - Persian: اراک، میدان بسیج، بیمارستان امیرکبیر، 3819693345
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 5075
Fax:
Email: mahmoodrezaie069@gmail.com
Web page address:
Name of recruitment center - English: Department of Pediatrics, Amir Kabir hospital
Name of recruitment center - Persian: بخش اطفال، بیمارستان امیرکبیر اراک
Full name of responsible person - English: Roghaie Rahimi Afzal
Full name of responsible person - Persian: رقیه رحیمی افضل
Street address - English: Amir Kabir hospital, Basij Square, Arak.
Street address - Persian: اراک، میدان بسیج، بیمارستان امیرکبیر
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 5075
Fax:
Email: mahmoodrezaie069@gmail.com
Web page address:
Name of recruitment center - English: Department of Pediatrics, Amir Kabir Hospitalhospital Name of recruitment center - Persian: بخش اطفال، بیمارستان امیرکبیر اراک Full name of responsible person - English: Roghaie Rahimi Afzal Full name of responsible person - Persian: رقیه رحیمی افضل Street address - English: 3819693345, Amir Kabir Hospitalhospital, Basij Square, Arak. Street address - Persian: اراک، میدان بسیج، بیمارستان امیرکبیر، 3819693345 City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3313 5075 Fax: Email: mahmoodrezaie069@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Arash Anoushirvani
Full name of responsible person - Persian: علی ارش انوشیروانی
Street address - English: 3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
Street address - Persian: اراک، سردشت، دانشگاه علوم پزشکی اراک، معاونت تحقیقات
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 5075
Fax:
Email: dr.eghbali@arakmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Arash Anoushirvani
Full name of responsible person - Persian: علی ارش انوشیروانی
Street address - English: Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
Street address - Persian: اراک، سردشت، دانشگاه علوم پزشکی اراک، معاونت تحقیقات
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 5075
Fax:
Email: dr.eghbali@arakmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ali Arash Anoushirvani Full name of responsible person - Persian: علی ارش انوشیروانی Street address - English: 3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak. Street address - Persian: اراک، سردشت، دانشگاه علوم پزشکی اراک، معاونت تحقیقات City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3313 5075 Fax: Email: dr.eghbali@arakmu.ac.ir Web page address:
Protocol summary
Study aim
Study of oral Liverghol impact on enzymes of liver in patients with major thalassemia and intermedia thalassemia .
Design
Clinical trial with a control group with parallel groups, two-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 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.
Participants/Inclusion and exclusion criteria
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.
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
Change the method from one blinded to two blinded
Acronym
IRCT registration information
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
Registration date
2019-01-17, 1397/10/27
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
2018-09-22, 1397/06/31
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Oral Liverghol Impact on Liver Enzymes in Patients with Thalassemia Major and Intermedia
Public title
Evaluation Liverghol Impact on Liver Enzymes
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
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)
Double blinded
Blinding description
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.
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
2018-11-30, 1397/09/09
Ethics committee reference number
IR.ARAKMU.REC.1397.109
Health conditions studied
1
Description of health condition studied
Thalassemia Major and Intermedia
ICD-10 code
D56
ICD-10 code description
Thalassemia
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
Blood and Oncology Diseases
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
Assistant Professor of Pediatric Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Blood specialist and oncology
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
Blood specialist and oncology
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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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