To determine whether adding alphapinen capsule as adjuvant to quadruple regimen in patients with Helicobacter pylori infection will increase the eradication rate.
Design
Design of the study is a double-blind, placebo-controlled, randomized control single center clinical trial. Patients with age more than 18 years old infected with Helicobacter pylori will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 78 patients were randomly divided into two control and intervention groups by Microsoft Excel software and a code was allocated to each one of them.
Settings and conduct
This study is conducted as placebo controlled double blinded randomized clinical trial in taleqani hospital participants and researcher all has been blinded. All patients will receive quadruple therapy for eradication of Helicobacter pylori. In addition patients will receive either alphapinen 10 mg/d capsule or placebo randomly. After 4 weeks rate of Helicobacter pylori eradication will be determined in each groups and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infected patients with Helicobacter pylori with obtaining written consent form
Exclusion criteria: pregnancy or breastfeeding
Intervention groups
Intervention group (alphapinen):Helicobacter pylori infected patients compatible with inclusion/exclusion criteria administrated with 10 mg alphapinen daily for 4 weeks. Control group (Alphapinen placebo): Helicobacter pylori infected patients compatible with inclusion/exclusion criteria administrated with 1 tablet of placebo daily for 4 weeks.
Main outcome variables
Eradication of Helicobacter pylori rate (in percent)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N15
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of alphapinen addition to quadruple therapy for the eradication of Helicobacter pylori gastrointestinal infectious
Public title
Effect of alphapinen addition to quadruple therapy for the eradication of Helicobacter pylori gastrointestinal infectious
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who infected with Helicobacter pylori on the basis of doing urease breath test
Obtaining written informed consent
Exclusion criteria:
Patients with previous history of allergy to alphapinen
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
1:1 randomization, centralized web-based randomization and according to the entry and exit criteria, through random allocation by balanced block method, individuals are divided into two groups of control and experimental. Using Random Sequence Generator, groups are created and people are placed in one of these two groups based on the reference sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo capsules in same size, shape color, odor and package with capsules of alphapinen which organized just by one responsible co-researcher has no involvement in running study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of pharmacy, nursing and midwifery of Shahid Beheshti university of medical science
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.020
Health conditions studied
1
Description of health condition studied
Infectious with Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Eradication of Helicobacter pylori
Timepoint
1month after finishing drugs
Method of measurement
Assesing the urease breath test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Addition ofalphapinen orally 10 mg/d to eradication regimen of Helicobacter pylori for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Addition of alphapinen placebo 1 capsule per day orally to eradication regimen of Helicobacter pylori for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Talighani hospital
Full name of responsible person
Mohammad Abbasinazari
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hassan Yazdanpanah
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8866 5282
Email
yazdanpanah@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacyو Nyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacyو Nyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
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
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after deidentified
When the data will become available and for how long
starting in ِJuly 2024
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
with written consent
From where data/document is obtainable
Sending email to: m_abbasi@sbmu.ac.ir
What processes are involved for a request to access data/document