The main aim of this study is evaluation of Helicobacter Pylori eradication in increasing of platelet count in Idiopathic thrombocytopenic purpura patients in comparison to placebo.
Adult with Idiopathic thrombocytopenic purpura that their Helicobacter Pylori serology is positive ,coming to this study and if they had past history of gastrectomy or treatment of Helicobacter Pylori excluded from study .
The population of our study are Idiopathic thrombocytopenic purpura patients, that coming to Babol University of Medical Sciences' clinics and volume of our samples is 30 patients.
In this study Helicobacter Pylori eradication will be performed by Clarithromycin and Amoxicillin for 2 weeks and the time of study is from 2012 to unlimit time that our case will be enough.
Out first outcome is increasing platelet count in patient comparison with placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202098968N1
Registration date:2012-12-15, 1391/09/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-15, 1391/09/25
Registrant information
Name
Mostafa Javanian
Name of organization / entity
Babol University of Medical Sciences-Tropical And Infectious diseases research center
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 0624
Email address
m.javanian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Helicobacter pylori eradication on recovery of platelet level in Idiopathic Trombocytopenic purpura patients
Public title
The effect of Helicobacter pylori eradication on recovery of platelet level in Idiopathic Trombocytopenic purpura patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusive Criteria:
Adult with diagnosis of idiopathic thrombocytopenic purpura; H. pylori stool antigen test Positive or positive urease breath test
Exclusive Criteria:
Family history of gastric cancer;History of treatment of H.Pylori infection; History of ulcer or inflammation in stomach or Duodenum.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afrouz Avenue,Babol, Mazandaran
City
Babol
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
30/6432/ژ/پ
Health conditions studied
1
Description of health condition studied
thrombocytopeny
ICD-10 code
D69.3
ICD-10 code description
Idiopathic thrombocytopenic purpura
Primary outcomes
1
Description
platelet count over than 100000
Timepoint
day 0,10,30,60,90,120,150,180 after drug
Method of measurement
Laboratory
Secondary outcomes
1
Description
Efficacy of treatment in eradication of H-Pylori
Timepoint
during 6 months(in days 0,10,30,60,90,120) after drug