Investigating the effect of sucralfate/sodium alginate capsules in patients with treatment-resistant gastroesophageal reflux disease (GERD)
Design
In this study, the control group receives a double dose of proton pump inhibitor for 30 days. The intervention group received ALSUC capsules containing 500 mg sucralfate and 500 mg sodium alginate for 30 days.
Settings and conduct
The refractory reflux patients are divided into two intervention and control groups after randomization. Blinding is not done. Patients are selected from Razi Hospital of Ilam
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who remained symptomatic (assessed by daily reflux questionnaire) with a standard dose of PPI after a trial period of treatment of at least 2 months.
Exclusion criteria: non-compliant; inappropriate use of PPI; Other diseases that can mimic the symptoms of GERD include achalasia, eosinophilic esophagitis, infectious esophagitis, pill esophagitis, gastroparesis, and esophageal stricture or cancer and functional dyspepsia according to the Rome4 criteria.
Intervention groups
Control group will receive double dose of proton pump inhibitor.
intervention group receive ALSUC capsules containing 500 mg sucralfate and 500 mg sodium alginate.
Main outcome variables
GERD symptoms severity and frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053263N3
Registration date:2024-05-09, 1403/02/20
Registration timing:registered_while_recruiting
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Shaahin Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 3960
Email address
mdkabe@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-03-15, 1402/12/25
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of capsules containing sucralfate/sodium alginate in patients with refractory gastroesophageal reflux disease
Public title
ALSUC in refractory GERD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who remained symptomatic (assessed by daily reflux questionnaire) with a standard dose of PPI after a trial period of treatment of at least 2 months.
Exclusion criteria:
non-compliant
inappropriate use of PPI
Other diseases that can mimic the symptoms of GERD include achalasia, eosinophilic esophagitis, infectious esophagitis, pill esophagitis, gastroparesis, and esophageal stricture or cancer and functional dyspepsia according to the Rome4 criteria.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used for random allocation. The size of the blocks will randomly selected. There are 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations are considered for the intervention group and two allocations for the control group. Random Allocation Software will be used for this purpose. The concealment will done using sequentially numbered, sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Ilam University of Medical Sciences
Street address
Banganjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.MEDILAM.REC.1402.237
Health conditions studied
1
Description of health condition studied
GERD
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
GERD symptoms severity and frequency during and 6 weeks after treatment
Timepoint
During intervention and 6 weeks after treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Compliance of patient
Timepoint
During intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: patients will receive cap ALSUC containing 500 mg sucralfate and 500 mg sodium alginate after each meal and at bedtime for 30 days.
Category
Treatment - Drugs
2
Description
Control group: the control group receive a double dose of Proton Pump Inhibitor before breakfast for 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Shaahin Shahbazi
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 21 8821 3960
Email
mdkabe@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abbas Maleki
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 21 8821 3960
Email
a_maleki@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 21 8821 3960
Email
mdkabe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 21 8821 3960
Email
mdkabe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 21 8821 3960
Email
mdkabe@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