Evaluation of the effect of oral curcumin on liver enzymes and liver T2*MRI in patients with major and intermediate thalassemia
Design
Clinical trials with control group, randomized assignment to intervention and control groups, double blind study, with a sample size of 80
Settings and conduct
This clinical trial study will carry out in patients with major and intermediate thalassemia referred to Ali Asghar Children's Hospital.The patients will be coded according to the order of entry and randomly divided into two groups of intervention and the control group. The intervention group will receive the Curcumin tablet. The control group will receive the placebo . All subjects entering the trial will be checked in terms of the level of liver enzymes including bilirubin, ALT, AST, ALP and ferritin. Liver T2 * MRI will be performed at the beginning and end of the study. Patients will be monitored for 6 months by measuring their level of liver enzymes on a monthly basis and will be compared in two groups at the end of 6 months.
Participants/Inclusion and exclusion criteria
Entry requirements: All patients with major and intermediate thalassemia. Exit conditions: Parental dissatisfaction; Renal failure; Hepatitis B; Hepatitis C; AIDS
Intervention groups
The intervention group will receive curcumin oral tablet. The control group will receive placebo.
Main outcome variables
Alanine Aminotransferase
Alkaline Phosphatase
Aspartate Aminotransferase
Total Bilirubin
Direct Bilirubin
ferritin
liver T2*MRI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201107049296N1
Registration date:2021-08-31, 1400/06/09
Registration timing:prospective
Last update:2021-08-31, 1400/06/09
Update count:0
Registration date
2021-08-31, 1400/06/09
Registrant information
Name
Aziz Eghbali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2268 8027
Email address
eghbali.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral curcumin on liver enzymes and liver T2*MRI in patients with major and intermediate thalassemia
Public title
Evaluation of the effect of oral curcumin on liver enzymes and liver T2*MRI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major and intermediate thalassemia
Exclusion criteria:
Parental dissatisfaction
Renal failure
Hepatitis B
Hepatitis C
AIDS
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
- A number plate or sheet is made for the total number of people in the case and control groups (numerical code from 1 to N).
- All plaques are placed in an opaque bag.
- Considering that half of the subjects are as Intervention group population and the other half are as the control group population, Half of the plaques are removed from the bag by drawing lots (based on the probabilistic sampling principles). The number of these plaques is considered as the code of the people receiving the real medicine and this code is also included on the real medicine packages. Obviously, the other codes will be related to the controls and حplacebo packages.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, only the main executor of the project will know the type of medication each patient receives, and by the end of the test, neither patient nor physician will know which patient is receiving medication or placebo. This will be done through the coding of patients and drugs. Meaning of the codes will be recognizable only to the main executor of the project.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran university of medical science., Next to Milad Tower., Hemmat Highway., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-09-29, 1399/07/08
Ethics committee reference number
IR.IUMS.REC.1399.627
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Alanine Aminotransferase
Timepoint
Measurement of serum Alanine Aminotransferase (ALT) levels At the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
2
Description
Alkaline Phosphatase
Timepoint
Measurement of serum Alkaline Phosphatase (ALP) levels at the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
3
Description
Aspartate Aminotransferase
Timepoint
Measurement of serum Aspartate Aminotransferase (AST) levels at the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
4
Description
Total Bilirubin
Timepoint
Measurement of serum Total Bilirubin levels at the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
5
Description
Direct Bilirubin
Timepoint
Measurement of serum Direct Bilirubin levels at the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
6
Description
Ferritin
Timepoint
Measurement of serum ferritin levels at the beginning of the study and 1, 2, 3, 4, 5 and 6 months after initiation of curcumin administration
Method of measurement
Blood test
7
Description
liver T2*MRI
Timepoint
Measurement of liver T2*MRI at the beginning of the study and 6 months after initiation of curcumin administration
Control group: receive placebo pill every 12 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tَehran Ali Asghar Children's Hospital
Full name of responsible person
Aziz Eghbali
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2304 6413
Email
eghbali.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
َAbas Motevalian
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Hwy
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
َAziz Eghbali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatric hematology oncology
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
eghbali.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aziz Egbali
Position
Associate professo
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric hematology oncology
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
eghbali.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric hematology oncology
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
eghbali.a@iums.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main data used in the analysis will be shared.
When the data will become available and for how long
Access date: 6 months after printing the results
To whom data/document is available
Scientific researchers
Under which criteria data/document could be used
It can be used only in scientific research.
From where data/document is obtainable
Email of the research executive
What processes are involved for a request to access data/document
1- Introducing research subject and researcher's organizational affiliation 2- Declaration of research objectives 3- Declaration of data usage process 4- Setting up research cooperation memorandum between research executives and applicants of data