Protocol summary

Summary
Goal of study: The goal of this study is consideration of the eradication rate of Helicobacter Pylori (HP) through standard triple therapy regime in comparison with adding licorice root extract to this regime. Designing of study: Randomized, clinical trial. Inclusion criteria to study: if all patients during endoscopic procedure with have positive rapid urease test (RUT), providing that not having the following condition: pregnancy؛ Previous usage Antiacid or bismuth during recent a month ؛ Gastrointestinal (GI) bleeding؛ the usage of alcohol or substance ؛ advanced chronic disease. Exclusion criteria from study: lack of willingness to continue the treatment؛ suffering the illness that needs to consume another drug. Sample size: 120 patient. Methods & Intervention: patient with gastric disorder who need endoscopic procedure and having positive RUT for HP entering into this study and divided into 2 groups. First group(A) are treated by Clarithromycin (500 mg twice a day) + Amoxicillin (1 gr twice a day) + Omeprazole (20 mg twice a day) for 2 weeks and second group(B) are treated by licorice root extracts ( D-Reglis 1 tab twice a day) adding to previous regime for the same duration. After finishing the main period of treatment they receive maintaining 4 weeks by omeprazole. Following two weeks of not taking any type of medicine then every patient is tested by stool antigen. Ultimately eradication rate of HP are compare in two groups. Intervention time: 2 weeks Primary outcome: Compare eradication of HP infection by stool antigen of HP between 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061718124N1
Registration date: 2015-06-21, 1394/03/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-21, 1394/03/31
Registrant information
Name
Ali Akbar Hajiaghamohammadi
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 0084
Email address
ahmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2015-06-19, 1394/03/29
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the eradication rate of Helicobacter pylori (HP) between standard triple therapy regime and licorice root extract adding to triple therapy regime in patients with helicobacter pylori infection
Public title
The consideration of the effectiveness of licorice root extract adding to triple therapy regime of Helicobacter Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria to study: if all patients during endoscopic procedure with have positive rapid urease test (RUT), providing that not having the following condition: pregnancy؛ Previous usage Antiacid or bismuth during recent a month ؛ Gastrointestinal (GI) bleeding or any complication of peptic ulcer disease (PUD) ؛ the usage of alcohol or substance ؛ advanced chronic disease: Diabetes mellitus, Hypertension, Cirrhosis, Cerebrovascular attack, Coronary artery disease & gastric cancer. Exclusion criteria from study: lack of willingness to continue the treatment؛ lack of willingness to complete the period of treatment ؛suffering the illness that needs to consume another antibiotic or non steroidal anti inflammatory drugs (NSAIDs) .
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin, iran
City
Qazvin
Postal code
Approval date
2015-01-08, 1393/10/18
Ethics committee reference number
9670/20/28

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori

Primary outcomes

1

Description
Stool antigen of HP
Timepoint
Two weeks after ending period of treatment
Method of measurement
Laboratoriaf

Secondary outcomes

empty

Intervention groups

1

Description
Clarithromycin (500 mg twice a day) + Amoxicillin (1 gr twice a day) + Omeprazole (20 mg twice a day) for 2 weeks. After finishing the main period of treatment they receive maintaining 4 weeks by omeprazole only
Category
Treatment - Drugs

2

Description
Intervention group: licorice root extracts ( D-Reglis 1 tab twice a day) adding to Clarithromycin (500 mg twice a day) + Amoxicillin (1 gr twice a day) + Omeprazole (20 mg twice a day) for 2 weeks. After finishing the main period of treatment they receive maintaining 4 weeks by omeprazole only
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital Specialty Clinic Qazvin
Full name of responsible person
Dr. Sedighe Reisian
Street address
velayat hospital, 22 bahman blvd, elahiye alley, qazvin, iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpoor
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin, iran
City
Qazvin
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, Qazvin 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
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr. Sedighe Reisian
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Metabolic Diseases Research Center, Bu-ali Sina Hospital, Bu-ali Sina St, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 0084
Fax
+98 28 3332 6033
Email
ahmohammadi@qums.ac.ir; SRMDFM@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr. Sedighe Reisian
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Metabolic Diseases Research Center, Bu-ali Sina Hospital, Bu-ali Sina St, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 0084
Fax
+98 28 3332 6033
Email
ahmohammadi@qums.ac.ir; SRMDFM@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr. Sedighe Reisian
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Metabolic Diseases Research Center, Bu-ali Sina Hospital, Bu-ali Sina St, qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 0084
Fax
+98 28 3332 6033
Email
ahmohammadi@qums.ac.ir; SRMDFM@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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