Protocol summary

Summary
Objectives According to the high incidence of Helicobacter pylori infection in Iran and antimicrobial effects of thyme, we aim to compare the rate of Helicobacter pylori eradication by standard regime and standard therapeutic regime plus thyme. Design This study is a not blinded clinical trial and patients after informed consent enroll in study and divide in two groups for interventions. Setting and conduct All subjects who fulfill our inclusion criteria randomly divide in two groups (30 patients in each group) and therapeutic interventions will perform. Participants including main inclusion criteria Patients with gastrointestinal symptoms who have upper gastrointestinal endoscopy with a positive urea breath test will enroll in study. Intervention Intervention group will receive a regimen including pantoprazole, amoxicillin, clarithromycin and thyme (gastrolite) and the control group will receive pantoprazole, amoxicillin, clarithromycin and placebo (instead of thyme). The dose of the prescribed drugs are as follows: pantoprazole tablets 40 mg two times per day, amoxicillin 1 g capsule two times per day, clarithromycin 500 mg capsules two times per day and thyme as capsule (gastrolite) every 8 hours and in the control group a placebo with similar appearance for 2 weeks. Then the pantoprazole (40 mg daily) continue for another two weeks, then after a two weeks washout period to avoid from false negative response, urea breath test is performed and results will be recorded. Main outcome variables Helicobacter pylori eradication (based on urea breath test)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102024625N1
Registration date: 2016-02-17, 1394/11/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-17, 1394/11/28
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Semnan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thyme combined effect of triple therapy regimen compared with the standard regimen alone in eradication of Helicobacter pylori infection in patients who referred with upper gastrointestinal symptoms.
Public title
Thyme combined effect of triple therapy regimen compared with the standard regimen alone in eradication of Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Positive result for urea breath test Exclusion criteria: Receiving of Helicobacter pylori eradication therapy during past six months.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij Boulvard, In front of governor
City
Semnan
Postal code
3519747167
Approval date
2015-05-19, 1394/02/29
Ethics committee reference number
IR.SEMUMS.REC.1394.8

Health conditions studied

1

Description of health condition studied
Helicobacter pylori eradication
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Primary outcomes

1

Description
Negative urea breath test
Timepoint
Six weeks after initiation of interventions
Method of measurement
Urea breath test

Secondary outcomes

1

Description
Eradication of Helicobacter pylori infection
Timepoint
Six weeks after interventions
Method of measurement
Urea breath test

Intervention groups

1

Description
Control group will receive a regimen including pantoprazole tablets 40 mg two times per day, amoxicillin 1 g capsule two times per day, clarithromycin 500 mg capsules two times per day and a placebo with similar appearance for 2 weeks. Then the pantoprazole (40 mg daily) continue for another two weeks, then after a two weeks washout period to avoid from false negative response, urea breath test is performed and results will be recorded.
Category
Placebo

2

Description
Intervention group will receive a regimen including pantoprazole tablets 40 mg two times per day, amoxicillin 1 g capsule two times per day, clarithromycin 500 mg capsules two times per day and thyme as capsule (gastrolite) every 8 hours. Then the pantoprazole (40 mg daily) continue for another two weeks, then after a two weeks washout period to avoid from false negative response, urea breath test is performed and results will be recorded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Ramin Seyfollahpoor
Street address
Basidj Boulevard, Amin Avenue
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basij Bulvard
City
Semnan
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 of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Atosa Najmoddin
Position
Internist/ Assisstant professor
Other areas of specialty/work
Street address
Kowsar hospital, Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
atousanajmodin@semums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
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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