The effect of oral prolio on hepatic parameters, patients with thalassemia major, and intremedia is determined.
Design
Double blind randomized clinical trial in Amir Kabir hospital in Arak. 40 patients with thalassemia major and Intermedia will be divided into two equal groups using block randomization method.
Settings and conduct
This clinical trial study will be performed on all patients with major beta-thalassemia over 5 years referred to Amir Kabir hospital. At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA method. patients will be randomly divided into two groups. In the experimental group, the patients with age under 12 will receive half tablet and patients over 12 years will receive one tablet (275 mg) of oral Prolio twice daily (every 12 hours) and the placebo group will receive two placebo tablet twice daily. Patients will be treated 6 months and each month liver function tests will be performed. Then the information will be recorded.
Participants/Inclusion and exclusion criteria
in :All patients with beta thalassemia major and intermedia over 5 years
Exit: Unwilling to participate
Intervention groups
At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group. In the experimental group, patients under the age of 12 years will receive half a tablet and over 12 years one oral tablet (275 mg) of Prolio every 12 hours and in the control group patients will receive placebo control twice daily.
Main outcome variables
Hepatic parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191010045050N1
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:0
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Azam Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 7359
Email address
azame7733@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral proliveon liver function in patients with major and intermediate thalassemia
Public title
Evaluation of the effect of oral prolive on liver function in patients with major and intermediate thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with beta thalassemia major and intermedia over 5 years
Exclusion criteria:
Patients not willing to participate in the study
Malignancy
Liver dysfunction
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block
Randomization Unit: Individual
Randomization Tool: Envelope Method
How to Build a Random Sequence: Using www.randomization.com
Explanation of concealment: Using non-transparent sealed envelopes with a random sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the researcher in this study will be aware of the study groups while the patients will be not aware of the type of drug being used. Also, the intern responsible for filling the checklists will be not aware of the type of medication consumed, and only will know the groups based on A and B and will fill out the checklists accordingly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Arak University of Medica sciences
Street address
Arak University of Medica sciences ,Basij square , Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.ARAKMU.REC.1398.087
Health conditions studied
1
Description of health condition studied
Major and intermedia thallassemia
ICD-10 code
D77
ICD-10 code description
Other disorders of blood and blood-forming organs in diseases classified elsewhere
Primary outcomes
1
Description
Liver enzyme
Timepoint
Before the intervention and after, every one month to six months
Method of measurement
Laboratory
2
Description
Total Billirubin and Total protein
Timepoint
Before the intervention and after, every one month to six months
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients with age under 12 will receive half tablet and patients over 12 years will receive one tablet (275 mg) of oral Prolio twice daily (every 12 hours) and repeat tests up to 6 months each months.
Category
Treatment - Drugs
2
Description
Control group: At baseline, liver enzymes levels of ALT, AST, total cholesterol, total protein, ALKp, total bilirubin and GGT will be measured by ELISA in the control group.patients will receive two placebo tablet twice daily (every 12 hours) and repeat tests up to 6 months each month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital in Arak
Full name of responsible person
Azam Ebrahimi
Street address
Nursing square , Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 4715
Email
Rsearch@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 4715
Email
Rsearch@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
Azam Ebrahimi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
91 Alley - Emam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
8139949551
Phone
+98 86 3312 7359
Email
azame7733@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Ebrahimi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
Alley 91 - Emam khomeini street
City
Esfahan
Province
Isfehan
Postal code
8139949551
Phone
+98 86 3312 7359
Fax
Email
www.azame7733@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Ebrahimi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
Alley 91 - Emam khomeini street
City
Esfahan
Province
Isfehan
Postal code
8139949551
Phone
+98 86 3312 7359
Fax
Email
www.azame7733@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