A clinical trial on the effects of green tea extract plus triple therapy regimen compared with triple therapy regimen on eradication of helicobacter Pylori in in patients diagnosed with helicobacter Pylori infection
This study compares the effects of triple therapy plus green tea extract regimen and the triple therapy regimen on eradication of helicobacter Pylori in patients diagnosed with helicobacter Pylori infection. A total of 60 outpatients infected with Helicobacter pylori who referred to the Gestation Clinic of Vali-e Asr Hospital of Birjand in 2016 were selected by convenience sampling method. The major inclusion criteria consisted of positive result of urease breath test (UBT) and rapid urease test for diagnosis of helicobacter pylori and having indications for Helicobacter pylori treatment. The participants were assigned into intervention and control groups (n = 30 per group) via simple allocation method. The intervention group received the routine triple therapy plus green tea extract pills (450 mg twice daily) for two weeks. The control group only received the routine triple therapy regimen for two weeks. Four weeks after completion of intervention, urease breath test was performed in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061317756N18
Registration date:2017-07-10, 1396/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Birjand University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effects of green tea extract plus triple therapy regimen compared with triple therapy regimen on eradication of helicobacter Pylori in in patients diagnosed with helicobacter Pylori infection
Public title
Eradication of helicobacter Pylori in triple therapy regimen supplemented by green tea extract compared with routine triple therapy regimen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Positive result of urease breath test (UBT) and/or rapid urease test for diagnosis of helicobacter pylori; having indications for Helicobacter pylori treatment; willingness to cooperate in the study; lack of green tea consumption by the patient prior to the study onset; no history of macrolide.
Exclusion criteria: Previous treatment for helicobacter pylori; consumption of proton pump inhibitors from a month before the test, or blockers of H2 receptor 24 hours before the test, or antibiotics and bismuth from two weeks before the test; pregnancy; malignancy; gastrectomy; severe liver disease or any other severe disease within the past two years; any sensitivity to penicillin or other substances used in the medication regimen; incomplete consumption of the drugs for any reason.
Age
No age limit
Gender
Both
Phase
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)
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 Birjand University of Medical Sciences
Street address
Vice-chancellery of Research and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
Ir.bums.REC.1395.288
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
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
Eradication of helicobacter pylori
Timepoint
Four weeks after intervention was completed
Method of measurement
Urease breath test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The intervention group received the routine triple therapy regimen plus green tea extract pill (450 mg twice daily) for two weeks. Four weeks after completion of intervention, urease breath test was performed.
Category
Treatment - Drugs
2
Description
Control Group: The control group only received the routine triple therapy regimen for two weeks. Four weeks after completion of intervention, urease breath test was performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gestation Clinic of Vali-e Asr Hospital
Full name of responsible person
Street address
Vali-e Asr Hospital, Ghaffari St.,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology at Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology at Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Laila Omidvar
Position
Assistant of Internal Diseases
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
Roozgar@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Laila Omidvar
Position
Assistant of Internal Diseases
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciecnes, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
roozgar@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vive-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)