Determination of the effect of alkaline water in patients with gastroesophageal reflux disease
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients with gastroesophageal reflux disease referred to Imam Ali Clinic and Prophet Rasul Clinic in Shahrekord will selected by convenience sampling and will randomly divided into two intervention and control groups of 36 each. The intervention group received alkaline water and the control group received ordinary mineral water. Gastrointestinal symptoms before and 6 weeks after the study will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Symptoms of gastroesophageal reflux disease at least 2 times a week for at least 3 months; Age between 18 to 40 years; Exclusion criteria: Any pathological problem associated with gastroesophageal reflux disease including Barrett's esophagus and malignancy; Having warning signs such as painful and difficulty swallowing, nausea, vomiting and fever
Intervention groups
Intervention group will receive at least 1.3 liters of alkaline water (bottle A) daily regardless of specific consumption pattern and based on routine consumption. The control group will receive 1.3 liters of ordinary mineral water (bottle B) daily.
Main outcome variables
Changes in gastrointestinal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042935N2
Registration date:2020-03-14, 1398/12/24
Registration timing:retrospective
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Abdolrahim Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 9507
Email address
kazemi.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of alkaline water in patients with gastroesophageal reflux disease
Public title
Effect of alkaline water in treatment of gastroesophageal reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptoms of gastroesophageal reflux disease at least 2 times a week for at least 3 months
Age between 18 to 40 years
Exclusion criteria:
Any pathological problem associated with gastroesophageal reflux disease including Barrett's esophagus and malignancy
Having warning signs such as painful and difficulty swallowing, nausea, vomiting and fever
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling will be done. To this end, 72 cards of the same size and shape will be labelled A and B one by one, and then patients will randomly pick one card in order of their enrollment in the study and will be assigned to either group according to the label of the card they picked.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study considering the use of similar bottles in all two groups, participants, researcher and the assessor, are not aware of the contents of the bottles and the groups will be checked with the names A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Research Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.SKUMS.REC.1397.122
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Mean scores of gastrointestinal symptoms in GERD questionnaire
Timepoint
Before the intervention and six-week after intervention
Intervention group: This group will receive at least 1.3 liters of alkaline water (bottle A) daily regardless of specific consumption pattern and based on routine consumption. For the preparation of alkaline water, ordinary mineral water is contacted with the catalyst and collected in a bottle and provided to the patient.
Category
Treatment - Drugs
2
Description
Control group: This group will receive 1.3 liters of ordinary mineral water (bottle B) daily regardless of specific consumption pattern and based on routine consumption.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Clinic of Shahrekord
Full name of responsible person
Doctor Ghorbanali Rahimian
Street address
Emam Ali Clinic of Shahrekord, Shariati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
ghorbanali.rahimian@gmail.com
Web page address
https://imamaliclinic.skums.ac.ir/
2
Recruitment center
Name of recruitment center
Prophet Rasul Clinic in Shahrekord
Full name of responsible person
Doctor Ghorbanali Rahimian
Street address
Prophet Rasul Clinic of Shahrekord, Molavi intersection
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3226 4833
Email
ghorbanali.rahimian@gmail.com
Web page address
https://rasulclinic.skums.ac.ir/#
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Ayatollah Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Fax
Email
mehr.sadeghi1ir@gmail.com
Web page address
https://research.skums.ac.ir
Grant name
Grant code / Reference number
2796
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Ghorbanali Rahimian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
ghorbanali.rahimian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Ghorbanali Rahimian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
ghorbanali.rahimian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Ghorbanali Rahimian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
ghorbanali.rahimian@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