Effect of zinc supplementation on the improvement of gastroesophageal reflux symptoms in patients who refferd to gastroentrology clinic of Razi hospital and include based on history, physical exams and frequency scale for the symptoms of
reflux questionnaire are diagnosed gastroesophageal reflux disease.Exclusion criteria: Age below 18 years old; pregnant; history of peptic ulcers; patients who have undergone abdominal surgery for any reason.This study is double blind experimental clinical trials.One hundred fifty patients based on endoscopy divided to two groups erosive reflux disease and non erosive reflux disease, then patients would be divided case and control with random block. For all case and control groups would be completed reflux diagnosis questionnaire with 15 questions.All patients treated with pantoprazole 40 mg daily for 2 months, zinc sulfate capsule 220 milligram for case group and placebo for control group would be administrated.After treatment, reflux detection questionaire would be completed for all patients again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305281155N16
Registration date:2014-09-02, 1393/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-02, 1393/06/11
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and liver disease research center of Guilan university of medical siences
Expected recruitment start date
2013-12-30, 1392/10/09
Expected recruitment end date
2014-12-30, 1393/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on the improvement of gastroesophageal reflux symptoms in patients referred to gastroentrology clinic
Public title
Effect of zinc supplementation on the improvement of gastroesophageal reflux symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who referred to gastroentrology clinic and based on history, physical exams and frequency scale for the symptoms of
gastroesophageal reflux disease questionnaire are diagnosed gastroesophageal reflux disease.
Exclusion criteria: Age below 18 years old; pregnant; history of peptic ulcers; patients who have undergone abdominal surgery for any reason
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Gastrointestinal and liver Disease Research Center
Street address
Sardar Jangale street -Razi hospital-Gastrointestinal and liver Diseases Research Center
City
Rasht
Postal code
41448-95655
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
sh-175
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux disease
ICD-10 code
k21
ICD-10 code description
Gastroesophageal reflux disease
Primary outcomes
1
Description
Gastroesophageal reflux disease treatment
Timepoint
3 months
Method of measurement
Frequency scale for the symptoms of gastroesophageal reflux disease questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group take tab pantoprazole 40 miligram one number daily, cap zinc sulfate 220 miligram one number daily during two months
Category
Treatment - Drugs
2
Description
Control group take tab pantoprazole 40 miligram one number daily, cap zinc placebo one number daily during two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal and liver disease research center
Full name of responsible person
Farahnaz Joukar
Street address
Sardar Jangle Ave-Razi hospital-Gastrointestinal and liver disease research center
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University Medical sciences, gastrointestinal and liver disease research center
Full name of responsible person
Farahnaz Joukar
Street address
Sardar jangle Ave, Razi hospital, gastrointestinal and liver disease research center
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University Medical sciences, gastrointestinal and liver disease research center
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
Gastrointestinal and liver disease research center
Full name of responsible person
Farahnaz Joukar
Position
Assistant professor of gastrointestinal and liver disease research center
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research center, Razi hospita, Sardar Jangal Ave.
City
Rasht
Postal code
955655-41448
Phone
+98 13 1553 5116
Fax
Email
f_jokar@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastrointestinal and liver Disease Research Center (GLDRC)
Full name of responsible person
Dr. Fariboraz Mansou-Ghanaei
Position
Head, Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research center, Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
00981315534951
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for updating data
Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr Maryam Bakhshandeh
Position
General Physician
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research cente, Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 4951
Fax
Email
bmaryamb@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)