The objective of this randomized interventional trial is to investigate and compare the efficacy of 2_week and 3_week prednisolone thrapy among the patients with ITP who have refered to private office and clinc of Arak Khansari hospital.
In this study 66 patients with ITP who meet the inclusion/exclusion criteria will be recruited and randomly assigned in to intervention or control group.
The patients in the intervention group, will receive prednisolone (1mg/kg/day) for 2 weeks and the patients in the control group will receive prednisolone (1mg/kg/day) for 3 weeks.
platelet count,blood pressure, recurrence and complications will be measured before and up to 6 months after intervention and compared between groups.
General information
Acronym
"ITP" , Immune Thrombocytopenic Purpura
IRCT registration information
IRCT registration number:IRCT201109147553N1
Registration date:2011-12-27, 1390/10/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-27, 1390/10/06
Registrant information
Name
Saiedeh Bakhshi
Name of organization / entity
Arak university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 3146
Email address
dr.bakhshi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of medical sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison of efficacy of 2_week and 3_week prednisolone thrapy in patients with Immune Thrombocytopenic Purpura at Arak Khansari hospital
Public title
duration of prednisolone thrapy in ITP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ITP with thrombocytopenia and normal CBC and normal peripheral blood smear.
exclusion criteria: secondary ITP due to some diseases such as: lupus, antiphospholipid syndrom,CLL and infections.
Age
From 12 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak university of medical sciences
Street address
Amir kabir Ave.
City
Arak
Postal code
Approval date
2011-07-21, 1390/04/30
Ethics committee reference number
2380ص90/2/پ
Health conditions studied
1
Description of health condition studied
ITP
ICD-10 code
D69.3
ICD-10 code description
immune thrombocytopenic purpura
Primary outcomes
1
Description
platelet count
Timepoint
monthly till 6 months after treatment course
Method of measurement
CBC-Diff. and Plt. count/micro liter
Secondary outcomes
1
Description
blood pressure
Timepoint
before and after treatment course
Method of measurement
via sphygmomanometer. mm.Hg
Intervention groups
1
Description
Intervention group: prednisolone (1mg/kg/day) for 2 weeks
Category
Treatment - Drugs
2
Description
control group:
prednisolone (1mg/kg/day) for 3 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital, Arak
Full name of responsible person
Dr.Saiedeh Bakhshi, MD, resident of internal medicine
Street address
Daneshgah Ave.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences and health services
Full name of responsible person
Dr.Ali Arash Anoushiravani
Street address
daneshgah Ave.
City
Arak
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 and health services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak university of medical sciences and health services
Full name of responsible person
Dr.saiedeh Bakhshi
Position
resident of internal medicine
Other areas of specialty/work
Street address
Internal Medicine department, Imam Ali hospital, Sardasht Ave.
City
Arak
Postal code
Phone
+98 86 1417 3622
Fax
Email
bakhshi_saideh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences and health services
Full name of responsible person
Dr.saiedeh Bakhshi
Position
resident of internal medicine
Other areas of specialty/work
Street address
Internal Medicine department, Imam Ali hospital, Sardasht Ave.
City
Arak
Postal code
Phone
+98 86 1417 3622
Fax
Email
bakhshi_saideh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical sciences and health services
Full name of responsible person
Dr.saiedeh Bakhshi
Position
resident of internal medicine
Other areas of specialty/work
Street address
Internal Medicine department, Imam Ali hospital, Sardasht Ave.
City
Arak
Postal code
Phone
+98 86 1417 3622
Fax
Email
bakhshi_saideh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)