This study will be done with aim to investigate the effectiveness of medications used to treat Helicobacter pylori infection on quality of life in chronic idiopathic urticaria . This study is a single blind clinical trial.
The study population will included all patients with chronic urticaria (CIU)with Helicobacter pylori infection refer to the Mohammad Kermanshahi hospital of Kermanshah city.
A total of 60 persons will be selected in available method and by permuted-block randomization will be assigned to two experimental and control groups. At baseline Quality of Life Questionnaire (CU-Q2OL) will be provided for both experimental and control groups,then in experimental group addition to the routine treatment of chronic urticaria, drug treatment OMC (Omeprazole, Metronidazole, Clarithromycin) will be prescribed for Helicobacter pylori infection for 2 weeks and the control group will receive usual treatment of chronic urticaria and placebo. In order to medication control, the patient during treatment for 2 weeks, at the end of the first week and the end of the second week refer physician to control. After the treatment course Ag stool exam test will be taken again to determine the effect of drugs on reducing Helicobacter pylori infection. A month after the start of the study and two months after treatment quality of life questionnaire will be provided to both groups again.
Inclusion criteria: Patients with chronic urticaria for at least 6 weeks.
Exclusion criteria: Pregnant and lactating women; people under 20 and over 40 years old; patients with severe Angioedema
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082114333N56
Registration date:2016-08-27, 1395/06/06
Registration timing:na
Last update:
Update count:0
Registration date
2016-08-27, 1395/06/06
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-09-10, 1395/06/20
Expected recruitment end date
2006-11-11, 1385/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of medications used to treat Helicobacter pylori infection on quality of life in chronic idiopathic urticaria
Public title
Effectiveness of medications used to treat Helicobacter pylori infection on quality of life in chronic idiopathic urticaria patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic urticaria for at least 6 weeks;Normal laboratory data and physical examination to detect the possible causes of chronic urticaria.
Exclusion criteria: Pregnant and lactating women; people under 20 and over 40years old; patients with severe Angioedema;Chronic alcoholics and patients with a history of recent use of proton pump inhibitors drugs, antibiotics and bismuth or non steroidal anti-inflammatory drugs or ACE
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
permuted-block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
kums.rec.1394.490
Health conditions studied
1
Description of health condition studied
Chronic urticaria
ICD-10 code
L50
ICD-10 code description
Utricaria
Primary outcomes
1
Description
Quality of life
Timepoint
Baseline, a month and two months after intervention
Method of measurement
Quality of Life Questionnaire (CU-Q2OL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group addition to the routine treatment of chronic urticaria,will received drug treatment OMC (Omeprazole, Metronidazole, Clarithromycin) for Helicobacter pylori infection for 2 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive usual treatment of chronic urticaria and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Maryam Taburak
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Seyed Hamid Mortezavih
Position
Immunologists
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
Mortezavih@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
Maryam Taburak
Position
Student of Medical
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
maryam_taburak@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)