Evaluation of the effect of Neurobion in patients with Thalassemia major
Design
یک کارآزمایی بالینی ، تصادفی ، کورکورانه و کنترل شده با طرح گروه موازی 40 بیمار ، که از اکتبر 2018 تا سپتامبر 2019 ثبت نام شدند و به مدت یک سال دنبال شدند.
Settings and conduct
A clinical trial, Random, blind and controlled with a parallel group design of 40 patients, who were registered from October 2018 to September 2019 and followed for one year.
Participants/Inclusion and exclusion criteria
All patients with Thalassemia major over 10 years of age
Intervention groups
The first group is treated with Thalassemia for 6 months, including regular transfusion, calcium and zinc sulfate, and folic acid in the presence of Neurobion that Neurobion will be given as an intramuscular injection every two weeks and then a one-month wash-out period to eliminate the possible effects of the drug.And then they will be treated for Thalassemia without Neurobion for the second 6 months and they will take a placebo and we will do the opposite for the second group.In this way, the first 6 months will be treated with Thalassemia without Neurobion and they will take a placebo and then the second 6 months will be treated with Thalassemia in the presence of Neurobion.Patients who will be treated with Neurobion will have a monthly CBC test after receiving Neurobion, Patients will complete two types of checklists during treatment, including a questionnaire containing demographic information and study variables, including: age, sex, blood transfusion intervals, history of splenectomy, type of supplement received, type of chelator and CBC test for Hb changes.
Main outcome variables
Change in the quality of life of patients with Thalassemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180602039941N1
Registration date:2020-09-29, 1399/07/08
Registration timing:retrospective
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Fateme Sahamipourdehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3464 2380
Email address
f.sahamipour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2020-07-22, 1399/05/01
Scientific title
The effectiveness of Neurobion in improving the general health of patients with thalassemia major referred to the hospital
Public title
The effect of Neurobion in the treatment of Thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Thalassemia major over 10 years of age
Exclusion criteria:
Patients who do not wish to participate in this plan
Patients with Hepatitis and Renal failure
Patients with Thalassemia major under 10 years of age
Patients with alloimmunization
Patients who do not receive Zinc sulfate, Calcium and Folic acid
Age
From 10 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Children with betaThalassemia major over 10 years of age willing to cooperate and sign informed written consent to participate in the study having at least two years of transfusion history at least 20 days after the last transfusion at the time of blood transfusion specific treatment with Deferoxamine ) Neurobion supplementation with Deferoxamine
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher, participants, physician, and statistical analyst were blinded in this study, meaning that none of the neurons consumed by the patients were known.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Amirkabir Hospital Clinical Research Development Center
Street address
Shahid Shiroudi St. - Parstar Sq. - Amirkabir Hospital, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.301
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of physical symptoms, anxiety, sleep disorder and depression in questionnaire number two
Timepoint
Measurement of monthly hemoglobin after neurobion injection
Method of measurement
Blood test and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty Patients with Thalassemia major over 10 years of age who receive Neurobion
Category
Rehabilitation
2
Description
Control group:Patients with Thalassemia major over the age of 10 receive a placebo
Arak city, University of Medical Sciences, University Complex of the Great Prophet (PBUH) Vice Chancellor for Research and Technology
City
Arak
Province
Markazi
Postal code
38481-76341
Phone
+98 86 3417 3639
Email
research@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
Fateme sahamipourdehqan
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Amirkabir hospital in Arak- Parstar square-Shahid Arak- city street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fateme sahamipour dehghan
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Amirkabir Hospital Arak- Parstar Square-Shahid Shiroodi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
dr.f.sahamipour14@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fateme sahami pour dehghan
Position
دانشجوی پزشکی عمومی
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Amirkabir Hospital, Arak- Parstar Sq- Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
it@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
Lack of access to complete personal information
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
No - There is not a plan to make this available
Title and more details about the data/document
After identifying individuals, some of the participants' personal data such as age, marital status, etc. will be shared in order to control confounding variables.
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
Researchers and students who need data for related research projects.
Under which criteria data/document could be used
Use of the present data is subject to the permission of all project partners. All statistical analyzes will be applicable to the data.
From where data/document is obtainable
Fateme Sahami Pour Deheqan
What processes are involved for a request to access data/document
With the permission of me Within one month, the data of this study will be sent to the applicant in an SPSS file.