Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Helicobcide in patients with Functional Dyspepsia: A Randomized Clinical Trial
Comparison of Helicobacter pylori treatment with four-drug regimen with helicobsid drug in people with indigestion.
Design
A clinical trial with a control group, double-blind, randomized, phase 3 on 112 patients, with randomization and random sequence construction, using a table of random numbers and through www.randomization.com.
Settings and conduct
Patients suffering from indigestion (without ulcers) with positive Helicobacter pylori infection will be included in the study in 1401 at the gastroenterology clinics affiliated to Mashhad University of Medical Sciences. Then randomly, one group of patients will be prescribed the four-drug regimen and the other group will be prescribed the drug Holcobsid once a day after lunch for one month. Demographic information, method of treatment, duration of treatment, response rate and result of stool exam ag before and after treatment will be recorded in the study checklist. Then the effectiveness of each of these two drug regimens will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria included Helicobacter pylori infection based on fecal antigen and not receiving four-drug treatment and not receiving antibiotics from the last two months until entering this study. Exclusion criteria included eradication of Helicobacter pylori and sensitivity to ginger.
Intervention groups
In the intervention group, helicobsid drug is prescribed to the patients in the form of oral capsules. In the control group, four standard drugs are prescribed.
Main outcome variables
Helicobacter pylori eradication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231227060546N1
Registration date:2024-01-30, 1402/11/10
Registration timing:prospective
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Maryam Anvary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
maryamanvary299@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Helicobcide in patients with Functional Dyspepsia: A Randomized Clinical Trial
Public title
patients with Functional Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 45 years
Consent to enter the study and take the prescribed drugs
Patients with functional dyspepsia (without ulcers)
The patient with Helicobacter pylori infection was Ag based on stool exam
Not receiving four-drug treatment and not receiving antibiotics from the last two months until entering this study
Exclusion criteria:
Uncompensated heart failure
Uncompensated liver failure
Dialysis patients
Patients with hematologic Malignancies
Patients treated with anticonvulsants
History of allergy to ginger
pregnancy
History of allergic disorders
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block-based and the randomization unit is a block of four. The randomization tool and random sequence construction is done using the random number table and through the website www.randomization.com. In this study, we have two groups (indicated by the letters A and B).
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering that this study will be designed in a double-blind manner, the patients, caregivers, and clinical evaluators are unaware of the contents of packages A and B. The drug and placebo will be produced in the faculty of pharmacology, and for proper blinding, the drug and the placebo will be completely similar in terms of color, size, and smell, and apart from the pharmacist, none of the participants and researchers will have access to them until the end of the study. They will not be aware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.248
Health conditions studied
1
Description of health condition studied
Dyspepsia (without ulcers) with positive Helicobacter pylori infection
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Eradication of Helicobacter pylori by antigen examination
Timepoint
A month afte3r completion of treatment
Method of measurement
Detection of Helicobacter pylori antigen in stool samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Taking Holcobside medicine (capsules containing 400 mg of ginger) once a day after lunch for one month
Category
Treatment - Drugs
2
Description
Control group: Treatment with four drugs including metronidazole, tetracycline, bismuth, a proton pump inhibitor such as pantoprazole, each once a day after lunch for a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
GI clinic of Imam Reza Hospital
Full name of responsible person
Dr Maryam Anvary
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3842 6936
Email
maryamanvary299@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Anvary
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Ward, Emam Reza Hospital, Emam Reza Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 3031
Fax
Email
maryamanvary299@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Anvary
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Ward, Emam Reza Hospital, Emam Reza Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 3031
Fax
Email
maryamanvary299@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Anvary
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Ward, Emam Reza Hospital, Emam Reza Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 3031
Fax
Email
maryamanvary299@gmail.com
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