This study aimed to investigate the effect of H. pylori eradication therapy increases platelet counts in adult patients with immunologic thrombocytopenia purpura (ITP) is performed. Inclusion criteria: patients with ITP and with Helicobacter pylori infection and treatment Exclusion criteria: patients with autoimmune disorders, HIV, hepatitis and drug-induced thrombocytopenia patients and patients of 2 years ago have received medical treatment against Helicobacter pylori. The project duration is 6 months. The sample size in each group is 25 people. If so and you get treated for 14 days then Hp Helicobacter Pylori Eradication is established. The effect of eradication therapy in patients with H. pylori infection than those with and without a treatment to eradicate H. pylori in patients with ITP to increase platelet count is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110930806N1
Registration date:2017-01-03, 1395/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Hossein Jebali
Name of organization / entity
Arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3278 4000
Email address
h.jebali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effectiveness of eradication therapy for H. pylori infection in adult patients with ITP
Public title
The effect of treatment of Helicobacter pylori infection in increasing platelet counts in patients with idiopathic thrombocytopeni
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with thrombocytopenia purpura ideopatic andy with Helicobacter pylori infection and treatment. Exclusion criteria: patients with autoimmune disorders؛ HIV؛ hepatitis؛ drug-induced thrombocytopenia؛ patients who two years ago against Helicobacter pylori have received medical treatment؛ patients at 4 weeks of antibiotic or protein pump inhibitors have used
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
College of Medical Sciences -Sardasht-Arak
City
Arak
Postal code
IR.ARAKMU.REC.1395.1
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.ARAKMU.REC.1395.145
Health conditions studied
1
Description of health condition studied
idiopathic thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Idiopathic thrombocytopenic purpura
Primary outcomes
1
Description
PLATELET
Timepoint
monthly
Method of measurement
CBC
Secondary outcomes
1
Description
Helicobacter pylori infection
Timepoint
monthly
Method of measurement
Helicobacter pylori antibody test
Intervention groups
1
Description
Intervention: people with eradication of H. pylori infection who were treated
Category
Treatment - Drugs
2
Description
control groups: those without infection with H. pylori infection is not treated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology Clinic - Hospital khansari
Full name of responsible person
Jebali Hossein
Street address
Hospital khansari-Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Aliarash Anoshiravani
Street address
Sardasht-Arak
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
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
University of Medical Sciences arak
Full name of responsible person
Jebali Hossein
Position
Internist Assistant
Other areas of specialty/work
Street address
Hospital Amiralmooemenin-Arak
City
Arak
Postal code
Phone
+98 86 3422 2257
Fax
Email
jebalihossein@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Dr Reza Aghabozorgi
Position
Hematologist and Oncologist
Other areas of specialty/work
Street address
Hospital Khansari -Arak
City
Arak
Postal code
Phone
+98 863417363
Fax
Email
rezaaghabozorgy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Jebali hossein
Position
Intrnist Assistan
Other areas of specialty/work
Street address
HospitaL Amiralmooemenin-Arak
City
Arak
Postal code
Phone
+98 86 3422 2257
Fax
Email
jebalihossein@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)