Objectives: The goal of this study is comparing the addition of cinnamon powder and placebo to the conventional treatment of Helicobacter Pylori infection.
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Setting and conduct: Eligible patients in the study will randomly allocate to intervention and control groups. The sample size is 76 patients in each group. The patients, executive researcher and the chief colleague will not aware of allocation of patients to intervention and control groups.
Participants: In this study the inclusion criteria will be the Patients with dyspepsia; nosea; vomiting and epigastric pain attending the gastrointestinal clinic of Velayat hospital and infectious diseases clinic of Bualisina hospital; with positive evidence of Helicobacter Pylori infection (stool antigen test). The exclusion criteria will be HIV infection ; known cases of malignancies.
Intervention: In this study, H. Pylori triple therapy regimen (clarithromycin + amoxicillin + omeprazole) will be administered to both the intervention and control groups for two weeks. In the intervention group, 400 mg Cinnamon powder in capsules will be added to the basic regimen in the twice daily schedule. In controls placebo capsules appeared quite similar to Cinnamon capsules will be prescribed with the same schedule.
main outcome variables: Helicobacter pylori stool antigen performed 6 weeks after the completion of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505032276N2
Registration date:2015-08-01, 1394/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Behzad Bijani
Name of organization / entity
Qazvin University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 4808
Email address
bbijani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
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 of the efficacy of addition of Cinnamon powder and placebo in eradication of Helicobacter Pylori infection, a clinical trial.
Public title
Effect of cinnamon in the treatment of Helicobacter Pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with dyspepsia; nosea; vomiting; epigastric pain attending gastrointestinal clinic of Velayat hospital and infectious diseases clinic of Bualisina hospital with positive evidense of Helicobacter Pylori infection (stool antigen test).
Exclusion criteria: HIV infection; known cases of malignancies.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
152
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 Qazvin University of Medical Sciences and Health Servises
Street address
5, Bahonar Blvd, Qazvin University of Medical Sciences and Health Servises
City
Qazvin
Postal code
59811-34197
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
28/20/10039
Health conditions studied
1
Description of health condition studied
helicobacter pylori B98.0
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 result of stool antigen of Helicobacter Pylori
Timepoint
6 weeks after the end of treatment
Method of measurement
Checking of H.Pylori stool antigen
Secondary outcomes
1
Description
Oral ulcer
Timepoint
During, end and till 6 weeks after end of treatment
Method of measurement
Patient report
2
Description
Epigasteric pain
Timepoint
During, end and till 6 weeks after end of treatment
Method of measurement
Patient report
3
Description
Skin rash
Timepoint
During, end and till 6 weeks after end of treatment
Method of measurement
Patient report
4
Description
diarrhea
Timepoint
During, end and till 6 weeks after end of treatment
Method of measurement
Patient report
Intervention groups
1
Description
Intervention group: clarithromycin 500 mg BD+ amoxicillin 1g BD+ omeprazole 20 mg BD + 400 mg Cinnamon powder in capsules BD for two weeks. (oral)
Category
Treatment - Drugs
2
Description
Control group: clarithromycin 500 mg BD+ amoxicillin 500 mg BD+ omeprazole 20 mg BD + placebo capsules appeared quite similar to Cinnamon capsules (twise daily) for two weeks. (oral)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Clinic, Velayat Hospital
Full name of responsible person
Arash Miroliayee
Street address
2, Velayat St, Minoodar Blvd
City
Qazvin
2
Recruitment center
Name of recruitment center
Infectious diseases Clinic, Bualisina Hospital
Full name of responsible person
Behzad Bijani
Street address
112, Buali St
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences and Health Servises
Full name of responsible person
Dr Taghi Naserpour
Street address
15, Shahid Bahonar Blvd, Vice Chancellor for Research, Qazvin University of Medical Sciences and Health services
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 and Health Servises
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
Qazvin University of Medical Sciences and health Servises
Full name of responsible person
Fatemeh Homayuni
Position
resident
Other areas of specialty/work
Street address
112, Buali St, Bualisina Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
homauni.h@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences and health Servises
Full name of responsible person
Behzad Bijani
Position
Assistant professor, Infectious Diseases Specialist
Other areas of specialty/work
Street address
112, Buali St, Bualisina Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
bbijani@qums.ac.ir; dr.bijani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences and health Servises
Full name of responsible person
Behzad Bijani
Position
Assistant Professor, Infectious Diseases
Other areas of specialty/work
Street address
112, Buali St, Bualisina hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
bbijani@qums.ac.ir; dr.bijani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)