Evaluation of the effect of soft gel containing essential oil of Satureja hortensis(pyloricin) on eradicating and clinical symptoms of Helicobacter pylori infection
Evaluation of the effect of soft gel containing essential oil of Satureja hortensis(pyloricin) on eradicating and clinical symptoms of Helicobacter pylori infection
Design
Randomized clinical trial, controlled with placebo, parallel, double blind, single center
Settings and conduct
This clinical trial is performed on 60 individuals with Helicobacterpylori infection which referred to Kashan Shahid Beheshti Hospital.Individuals based on table of random numbers will be divided to routin treatment+ pyloricin or placebo soft capsule,BID for 2 weeks. All drug are presented in the same package and the physician and patients are blind .After analyzing data, codes will be decoded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of Helicobacter Pylori infection؛ Patients with functional dyspepsia or gastroduodenal ulcer have indications of eradication of Helicobacter pylori infection
Exclusion criteria: A person with advanced chronic disease؛ Any allergy to the drugs used in the study؛ Pregnancy or breastfeeding؛ Smoking and alcohol؛ Having a history of treatment to eradicate Helicobacter pylori infection؛ Taking antibiotics or bismuth 4 weeks before entering the study؛ Constipation
Intervention groups
Intervention group: Routin treatment(Omeprazole20(Produced in Abidi Pharmaceutical Company) +Amoxicillin1+ Clarithromycin500(Produced in Toliddaru Pharmaceutical Company) BID)+Herbal soft capsule contain essential oil of Satureja hortensis(Produced in Barij essence Pharmaceutical Company) ,BID for 2 weeks orally.
Control group:Routin treatment(Omeprazole20(Produced in Abidi Pharmaceutical Company) +Amoxicillin1+ Clarithromycin500(Produced in Toliddaru Pharmaceutical Company) BID)+ placebo soft capsule(Produced in Barij essence Pharmaceutical Company), BID for 2 weeks orally.
Main outcome variables
Clinical signs؛ eradication rate of helicobacter pylori
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N27
Registration date:2018-09-19, 1397/06/28
Registration timing:registered_while_recruiting
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of soft gel containing essential oil of Satureja hortensis(pyloricin) on eradicating and clinical symptoms of Helicobacter pylori infection
Public title
Evaluation of the effect of pyloricin soft gel on Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Helicobacter Pylori infection by gastroenterologist with the help of a sample of pathology taken in the endoscopy or a positive result of anti-Helicobacter pylori antibodies in the serum sample of patients
Patients with functional dyspepsia or gastroduodenal ulcer have indications of eradication of Helicobacter pylori infection
Exclusion criteria:
A person with advanced chronic disease
Any allergy to the drugs used in the study
Pregnancy or breastfeeding
Substance abuse or alcohol use
Having a history of treatment to eradicate Helicobacter pylori infection
Taking antibiotics or bismuth 4 weeks before entering the study
Constipation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized based on table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Coding and similar packaging. The physician, patient, researcher and statistical analyzer are blind. At the end of the study and analysis of data, codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۸۸۱۴۱
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.008
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Clinical signs
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
2
Description
eradication rate of helicobacter pylori
Timepoint
after 1 months from the end of treatment
Method of measurement
stool antigen for helicobacter pylori
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Routin treatment(Omeprazole20(Produced in Abidi Pharmaceutical Company) +Amoxicillin1+ Clarithromycin500(Produced in Toliddaru Pharmaceutical Company) BID)+ Herbal soft capsule contain essential oil of Satureja hortensis(Produced in Barij essence Pharmaceutical Company) ,BID for 2 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Routin treatment(Omeprazole20(Produced in Abidi Pharmaceutical Company) +Amoxicillin1+ Clarithromycin500(Produced in Toliddaru Pharmaceutical Company) BID)+placebo soft capsule (Produced in Barij essence Pharmaceutical Company), BID for 2 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
dr Mohhamad Reza Molaghanbari
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
mollaghanbari-m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss Laleh Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
1178
Phone
+98 86 4854 0000
Email
info@barijessence.com
Web page address
http://www.barijessence.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
hamiidi@yahoo.com
Web page address
http://kaums.ac.ir
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 Kashan University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
M.Taghizadeh
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
kashan university of medical sciences.kashan
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۸۸۱۴۱
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۸۸۱۴۱
Phone
+98 36 1555 0021
Fax
+98 31 5557 1112
Email
taghizadeh_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Barij research center of medicinal herbs
Full name of responsible person
M.Mahlouji
Position
Expert in clinical research
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
KM 44 Kashan-Mashhad Ardehal
City
Kashan
Province
Isfehan
Postal code
3759111134
Phone
+98 86 4854 0000
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available