Comparison of the effect of eating and drinking modification and sumac capsule with omeprazole on reducing the symptoms of functional dyspepsia in adults
Design
This study is a clinical trial with four parallel groups that without blinding It will be performed on 104 patients. Patients will be assigned to one of four groups based on a random allocation with octet blocks.
Settings and conduct
This study is performed in Dr. Mousavi Hospital in Gorgan. In this study, which will be performed as a clinical trial without blindness, 104 patients with a diagnosis of functional dyspepsia are included in the study according to the inclusion criteria. After random allocation, patients will be divided into four groups who will be treated with medication or eating and drinking modification training in the first 4 weeks and will be monitored in the second 4 weeks. Data collection will be done by completing questionnaires by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness and satisfaction of the patient to participate in the study, functional dyspepsia (based on ROME III criteria), the presence of normal endoscopy without specific pathological findings, no infection with Helicobacter pylori, no antibiotics and PPIs during the last 1 month
Exclusion criteria: Underlying diseases including heart failure; Renal and hepatic failure; Cirrhosis; Diabetes, thyroid disorders, smoking, any drugs or alcohol, taking NSAIDs or aspirin, pregnancy or breastfeeding
Intervention groups
Group A patients will receive training on Eating and Drinking Modification and sumac extract capsule, group B patients will receive training on Eating and Drinking Modification, group C patients will receive sumac extract capsule and group D patients will receive omeprazole capsule.
Main outcome variables
Severity of dyspepsia symptoms; Quality of Life; Eating and drinking habits
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200424047192N1
Registration date:2021-01-24, 1399/11/05
Registration timing:registered_while_recruiting
Last update:2021-01-24, 1399/11/05
Update count:0
Registration date
2021-01-24, 1399/11/05
Registrant information
Name
Mahdi Saravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1653
Email address
saravani.m@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of eating and drinking modification and sumac capsule with omeprazole on functional dyspepsia symptoms in adults
Public title
The effect of eating and drinking modification and sumac in the treatment of dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age range between 18 and 60 years
Detection of functional dyspepsia (based on ROME III criteria)
Existence of normal endoscopy without specific pathological findings
The onset of symptoms is at least 6 months in advance and the presence of symptoms at least 3 days a week in the last three months
Absence of Helicobacter pylori infection
No history of treatment with antibiotics and PPIs during the last 1 month
Exclusion criteria:
Underlying diseases including heart failure; renal and hepatic failure; dirrhosis; diabetes, thyroid disorders
Smoking, drug or alcohol use
Consumption NSAIDs or aspirin
Pregnancy or breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be assigned to one of the following four groups based on a random allocation with octet-blocks previously generated by the Statistics and Methodology Consultant:
A- Treatment with eating and drinking modification + sumac capsules
B- Treatment with eating and drinking modification
C- Treatment with sumac capsules
D- Treatment with omeprazole capsules
In this study, the number of octet- blocks will be 13. These blocks have 4 letters and each letter has two repetitions. For example, four octet-blocks could be as follows:
DCBCDABA, CDBACDAB, ABBCDADC, BACADBCD
Accordingly, the first person who enter the study will be assigned to group D, ie treatment with omeprazole capsules, the second person to group C, ie treatment with sumac capsule, and In the same way, assigning participants to study groups up to the last person will be done based on the letters of pre-made blocks.
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
Ethics committee of Golestan Univercity of Medical Sciences
Street address
Phalsaphy complex, Shast kola Road
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.GOUMS.REC.1399.298
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Total score of gastrointestinal symptom rating scale
Timepoint
At baseline, 2, 4 and 8 weeks after starting the intervention
At baseline, 2, 4 and 8 weeks after starting the intervention
Method of measurement
10‐item short form of Nepean Dyspepsia Index (NDI-10)
3
Description
Eating and drinking habits
Timepoint
At baseline, 2, 4 and 8 weeks after starting the intervention
Method of measurement
Eating and drinking habits questionnaire
Secondary outcomes
1
Description
Drug side effects
Timepoint
During the intervention and up to one month after the end of the intervention
Method of measurement
Drug side effects questionnaire
Intervention groups
1
Description
First intervention group: observing eating and drinking modification + one capsule of sumac extract after each meal (three times a day). At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior. In addition, patients in this group will receive 42 capsules of sumac extract on the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way.
Category
Treatment - Drugs
2
Description
Second intervention group: observing eating and drinking modification. At the first visit (day zero), patients in this group will receive a specific and identical training package including written instruction sheets as well as oral explanations from a PhD student in traditional medicine about following the correct eating and drinking habits and behavior.
Category
Lifestyle
3
Description
Third intervention group: one capsule of sumac extract after each meal (three times a day). Patients in this group will receive 42 capsules of sumac extract in the first visit (day zero), of which 3 capsules will be consumed every day as one after each meal. In the second visit, which will be done two weeks after the start of the study, 42 capsules of sumac extract will be delivered to them for consumption in the same way.
Category
Treatment - Drugs
4
Description
Control group: one omeprazole capsule before breakfast (once a day). Patients in this group will receive 14 capsules of 20 mg omeprazole in the first visit (day zero), which will be taken one capsule per day before breakfast. In the second visit, which will be done two weeks after the start of the study, 14 capsules of 20 mg omeprazole will be delivered to them for consumption in the same way.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mousavi Hospital
Full name of responsible person
Mahdi Saravani
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.msaravani91@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research and Technology of Gorgan University
Street address
Vice-chancellor of Research and Technology, Gorgan University of Medical Sciences, 5 Km Gorgan, Sari Road
City
Gorgan
Province
Golestan
Postal code
4991555876
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Web page address
http://goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mahdi Saravani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.msaravani91@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahdi Saravani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.msaravani91@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahdi Saravani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
dr.msaravani91@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