First of all we select the patients with ITP(platelet<150000 and minimum time is 6 month) whoom come to Dr. Mohammad kermanshahi hospital.Then we check up helicobacter infection by examinating stool antigene(by Acon kit) so with permutation block methods patient with helicobacter pylori infection divided into intervention and control groups. We try that patients in each group with age and sex to be simillar.The basic therapy of ITP(Glucocorticoide) gives to each group.In intervention group anti helicobacter regiemen(omeperazole, clarithromycine, metronidazole) also gives.Then we study the eradication of helicobacter by stool antigene test.In this study we need 12 patient with helicobacter infection under anti helicobacter regiemen and 12 patient with helicobacter infection doesnt recieve anti helicobacter therapy.Then with completing the data form and statics search we compare the effect of helicobacter eradication at platelet condition in ITP patients(until 3 months after treatment monthly).Also,considering ITP is a chronic disease based on physician emphases the consumption of drug will control.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603077677N4
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Mohamadreza Golpayegani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6331
Email address
golpayegani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Helicobacter Pylori eradication on the level of platelet in chronic Idiopathic Thrombocytopenic Purpura patients
Public title
The effect of Helicobacter Pylori eradication on the level of platelet in chronic Idiopathic Thrombocytopenic Purpura patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: platelet level<150000 and time of ITP> 6 months; rule out other causes decreasing platelet level; helicobacter pylori infection that diagnosed by stool anti-gene test.
Age
From 11 months old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Kemanshah University of Medical Sciences
Street address
Building No.2, Kemanshah University of Medical Sciences, Shahid Beheshti blvd., Kermanshah
City
Kermanshah
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.KUMS.REC.1394.329
Health conditions studied
1
Description of health condition studied
chronic idiopathic thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Idiopathic Thrombocytopenic purpura
Primary outcomes
1
Description
Platelet level
Timepoint
Before intervention, 1 month, 2 months and 3 months after intervention.
Method of measurement
Blood platelet level (CBC)
Secondary outcomes
empty
Intervention groups
1
Description
tab metronidazole 500mg each 12h
tab clarithromycine 500 or 250 mg each 12h
tab omeperazole 20 mg each 12h
duration of treatment is 3 weeks(21 days)
Category
Treatment - Drugs
2
Description
in control group according to the coordination with pharmacy company and gastroenterologist the placebo therapy will give
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Kermanshahi hospital
Full name of responsible person
Street address
Dr. Mohammad Kermanshahi hospital, Red Crescent crossroad, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behrooz Hamzeh
Street address
Building no.2 of kums-shahid beheshti blvd.-kermanshah
City
Kermanshah
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
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Golpayegani
Position
Hematologist and oncologist
Other areas of specialty/work
Street address
Dr. Mohammad Kermanshahi hospital, Red Crescent crossroad, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3721 8207
Fax
Email
golpayegani@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Golpayegani
Position
Hematologist and oncologist
Other areas of specialty/work
Street address
Dr. Mohammad Kermanshahi hospital, Red Crescent crossroad, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3721 8207
Fax
Email
golpayegani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Golpayegani
Position
Hematologist and oncologist
Other areas of specialty/work
Street address
Dr. Mohammad Kermanshahi hospital, Red Crescent crossroad, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3721 8207
Fax
Email
golpayegani@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)