Determination of the effect of Cinnamon extract as the additional treatment of Helicobacter Pylori
Design
A double-blind, randomized clinical trial with the control group
Settings and conduct
Patients referred to the gastroenterology clinic of Beheshti Hospital in Hamadan. Blinding is done for researcher, physician, pharmacist and the data analyzer
Participants/Inclusion and exclusion criteria
Inclusion criteria: Dyspepsia symptoms, positive evidence of Helicobacter pylori during biopsy. Exclusion criteria: upper gastrointestinal (Duodenal) bleeding, pregnancy and lactation, liver disorders, renal failure and heart failure, history of allergy to the drugs under study and cinnamon, previous treatment of Helicobacter Pylori, corticosteroid and bismuth consumption, history of alcohol use
Intervention groups
In the treatment group, the cinnamon extract will be added to the basal diet in the form of a 40 mg-capsule twice a day.
In the control group, placebo capsules which are the same as cinnamon capsules in appearance and contain starch are given through a 40mg-capsule twice a day.
Main outcome variables
Eradication of Helicobacter Pylori
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121114011469N3
Registration date:2018-08-20, 1397/05/29
Registration timing:prospective
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Arezou Karampourian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0572
Email address
a.karampourian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-21, 1397/05/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of cinnamon extract as an adjuvant therapy in eradication of Helicobacter pylori in patients with Helicobacter pylori
Public title
Effect of cinnamon in treatment of gastric ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dyspepsia symptoms
Positive test for Helicobacter pylori at biopsy
Exclusion criteria:
Duodenal gastrointestinal bleeding
Pregnancy and lactation
Liver disorders, Kidney failure, Heart failure
History of allergy to the drugs undef study and cinnamon
Previous treatment of Helicobacter Pylori
Current using of corticosteroids and Bismuth
History of alcohol consumption
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for inclusion in the study will be allocated to two treatment and control groups using random numbers and two color cards.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher, physician, medicine deliverer and the data analyzer will not know the allocation of the patient to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Mardom Blvd.
City
Hamadan
Province
Hamadan
Postal code
6834568
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.135
Health conditions studied
1
Description of health condition studied
Peptic ulcer
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified
Primary outcomes
1
Description
Eradication of Helicobacter Pylori
Timepoint
Three months after initiation of treatment
Method of measurement
Urease respiratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the treatment group, the cinnamon extract will be added to the basal diet in the form of 40 mg capsules , twice a day for 14 days.
Category
Treatment - Drugs
2
Description
Control group: In the control group, placebo 40 mg capsules, with a completely similar appearance of cinnamon capsules and containing starch, twice a day for 14 days are given.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology clinic of Beheshti Hospital in Hamadan
Full name of responsible person
Ghazal Imani
Street address
Mardom Blvd
City
Hamadan
Province
Hamadan
Postal code
6856746
Phone
+98 81 3822 4045
Email
ghazalimani.pharmacy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Research and Technology Deputy head
Street address
Mardom Blvd
City
Hamadan
Province
Hamadan
Postal code
6856789
Phone
+98 81 3838 1810
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Imani Ghazal
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Mardom Blvd
City
Hamadan
Province
Hamadan
Postal code
6875490
Phone
+98 81 3822 4045
Email
ghazalimani.pharmacy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpoya
Position
Faculty Member of Hamedan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Mardom Blvd
City
Hamadan
Province
Hamadan
Postal code
67895439
Phone
+98 81 3838 0447
Email
m.mehrpoya@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ghazal Imani
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Mardom Blvd
City
Hamadan
Province
Hamadan
Postal code
68754390
Phone
+98 81 3822 4045
Email
ghazalimani.pharmacy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total data after unidentifiable participants can be shared.
When the data will become available and for how long
After the end of the study
To whom data/document is available
Researchers working in academic centers, as well as those engaged in the industry, can apply for them.
Under which criteria data/document could be used
For the treatment of patients
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Requesting information is possible through the author's email at the end of the study.