A comparative study on the effectiveness and complications of Desferal and Desphonac in thalassemic patients
Design
This study is a one-blinded clinical trial.The study population will be included of all patients that receive iron chelator and referred to thalassemia department Mohammad Kermanshahi hospital.A total of 98 eligible patients will be selected conveniently and randomly will be assigned to two intervention groups.
Settings and conduct
This study which will be conducted in Mohammad Kermanshahi hospital is one-blinded one that participants do not know what drug they will receive.At the beginning of the study, renal, hepatic, ferritin and iron tests will be performed in both groups and the data will be recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with thalassemia intermedia and thalassemia major
Exclusion criteria:Patients with hypertension, skin diseases, liver complications, and respiratory and auditory diseases
Intervention groups
The second intervention group will receive desferal for 8 consecutive days in the weekend for five consecutive days through the pump. The first intervention group will receive desferal for 8 consecutive days in the weekend for five consecutive days through the pump
Main outcome variables
Respiratory status;Digestive complications; Skin complications; Kidney and liver complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N117
Registration date:2019-03-17, 1397/12/26
Registration timing:registered_while_recruiting
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effectiveness and complications of Desferal and Desphonac in thalassemic patients in Kermanshah 2018-2019
Public title
Comparison of the effectiveness and complications of Desferal and Desphonac in thalassemic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with intermedia and major thalassemia
Exclusion criteria:
Renal patients
Patients with hypertension, skin diseases, liver complications, and respiratory and auditory diseases
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Individually randomization by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be blinded to the study groups, dosage of the drug and the manufacturer of the drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
ir.kums.rec.1397.930
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
respiratory status
Timepoint
Beginning of the study and end of the study (three months later)
Method of measurement
According to clinical symptoms and asking patients
2
Description
Digestive complications
Timepoint
Beginning of the study and end of the study (three months later)
Method of measurement
According to symptoms and asking patients
3
Description
Skin complications
Timepoint
Beginning of the study and end of the study (three months later)
Method of measurement
According to clinical symptoms and asking patients
4
Description
Renal and hepatic complications
Timepoint
Beginning of the study and end of the study (three months later)
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive desferal for 8 consecutive days in the weekend for five consecutive days through the pump
Category
Treatment - Drugs
2
Description
The second intervention group will receive desferal for 8 consecutive days in the weekend for five consecutive days through the pump
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Nargece Soraya
Street address
Intersection Helal Ahmar
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
nargece.soraya@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nargece Soraya
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Intersection Helal Ahmar
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
nargece.soraya@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. MohammadReza Golpayegani
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Intersection Helal Ahmar
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8207
Email
mrgolpayegani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nargece Soraya
Position
Resident of children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Intersection Helal Ahmar
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
nargece.soraya@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail