Effects of cetrizine on symptoms and histologic changes (count of mast cells) of gastric mucosa in patients with proton pump inhibitor resistant functional dyspepsia.
The study evaluates the effects of cetrizine on symptoms and histological changes (count of mast cells) of gastric mucosa in patients with proton pump inhibitor resistant functional dyspepsia. The patients with the diagnosis of functional dyspepsia who had undergone esophagogastroduodenoscopy and biopsy of antrum and body will be enrolled in the study. A sample volume of 30 patients is considered being a pilot study. The cases with other medical conditions or pathologic changes explaining the symptom of dyspepsia or a positive H.pylori on RUT or biopsy will be excluded. The patients fill a check list evaluating the severity of symptoms and ROME III questionnaire. The specimen will be stained with H & E and (if H. pylori infection is not found) toluidine blue. The eligible patients are treated with cetrizine 10 mg/qhs with ranitidine 150 mg/bid for 6 weeks. At the end of the treatment period, another checklist about severity of the symptoms and drug side effects will be introduced and a second endoscopy with biopsy of antrum and body with the same histological evaluation will be performed. Change in the mast cell count and its correlation with symptoms will be assessed as primary aims of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121211738N1
Registration date:2013-01-19, 1391/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-19, 1391/10/30
Registrant information
Name
Kurosh Masnadi Shirazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7554
Email address
masnadik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cetrizine on symptoms and histologic changes (count of mast cells) of gastric mucosa in patients with proton pump inhibitor resistant functional dyspepsia.
Public title
Effect of cetrizine on functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1. Fulfillment of ROMEIII criteria
2. Absence of any underlying medical disorder
3. Normal routine lab tests hepatoblliary ultrasound
4. Unrevealing esophagogastroduodenoscopy
5. Negative result of H. pylori tests
Exclusion criteria
Diagnosis anothert underlying cause for dyspepsia, incompliance (more than 10 % missed doses of medication ), positive H. pylori tests, History of taking antihistaminics in passed 3 minthes.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Before/after study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah street.
City
Tabriz
Postal code
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
5/4/7938
Health conditions studied
1
Description of health condition studied
Functional Dyspepsia
ICD-10 code
K31
ICD-10 code description
functional disorders of stomach
Primary outcomes
1
Description
Mast cell count in histologic study of gastric mucosa
Timepoint
Before and after a course of treatment
Method of measurement
Mean of mast cell count in high power fields of gastric mucosa stained with toluidine blue
Secondary outcomes
1
Description
Change in severity of symptoms
Timepoint
Before and after the treatment course
Method of measurement
A checklist of multiple choice question
Intervention groups
1
Description
cetrizine 10 mg at bedtimes for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Sheikhorrais and Emamreza hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kurosh Masnadi shirazi MD
Street address
Tabriz University of Medical Sciences, Golgasht ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sadrkabir
Position
Fellow of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Emamreza hospital,Endoscopy ward, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1334 7289
Fax
Email
sadrkabir@gmail.com , sadrkabir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sadrkabir
Position
Fellow of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Emamreza hospital, Golgasht ave.
City
Tabriz
Postal code
00984113347289
Phone
00894113347289
Fax
Email
sadrkabir@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sadrkabir
Position
Fellow of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)