Determining the effects of Buspirone on patients with functional dyspepsia referred to gastrointestinal clinics in Sari
Design
This is a randomized double-blind clinical trial with a control group. In this study, 40 Patients with dyspeptic symptoms for at least 3 months and and normal endoscopy who will refer to gastrointestinal clinic of Imam Khomeini Hospital of Sari will enter the study. They will be divided into 2 groups with block randomization method. One group will receive tablets of Buspiron 5 mg three times daily during the first month and tablets of Buspiron 10 mg three times daily during the second month. Placebo group patients will receive placebo tablets 3 times daily during the whole 2 months.
Settings and conduct
This is a randomized double-blind clinical trial with a control group. In this study, 40 patients with functional dyspepsia who will refer to gastrointestinal clinic of Imam Khomeini Hospital of Sari during January 2019 until June 2019 will enter the study. They will be divided into 2 groups with block randomization method.
Participants/Inclusion and exclusion criteria
40 Patients with dyspeptic symptoms for at least 3 months and and normal endoscopy who will refer to gastrointestinal clinic of Imam Khomeini Hospital of Sari will enter the study.
Intervention groups
The first group of patients will receive Buspirone ( 5 mg three times daily during the first month and 10 mg three times daily during the second month) and the next group will receive placebo tablets (3 times daily during the whole 2 months).
Main outcome variables
Effects of Buspirone on abdominal bloating induced by functional dyspepsia; Effects of Buspirone on early satiety induced by functional dyspepsia; Effects of Buspirone on post postprandial fullness induced by functional dyspepsia; Effects of Buspirone on functional dyspepsia in comparison to placebo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180405039198N1
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Tarang Taghvaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 0099
Email address
tarang_taghvaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Buspirone on patients with functional dyspepsia
Public title
effects of Buspirone on functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having dyspeptic symptoms for at least 3 months
Normal upper gastrointestinal endoscopy
Exclusion criteria:
History of psychological diseases
History of gastric or esophageal surgery
Having Celiac disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used. so that patients were classified in 5-patients blocks according to their age and gender.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the satistician are blind to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Amir mazandaranin street
City
Sari
Province
Mazandaran
Postal code
4816613135
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.MAZUMS.IMAM HOSPITAL.rec.1397.085
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
Therapeutic effect
Timepoint
Before starting the study and then after two months
Method of measurement
Questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients in this group will receive 3 tablets of Buspirone 5 mg (Iran Daru company) daily during the first month and three 10 mg tablets during the second month.
Category
Treatment - Drugs
2
Description
Control group: The patients in this group will receive 3 palcebotablets daily for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Tarang Taghvaei
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
tarang_taghvaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
tarang_taghvaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Amir Mazandarani
City
Sari
Province
Mazandaran
Postal code
4816613134
Phone
+98 11 3377 1760
Email
tarang_taghvaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Amir Mazandarani
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
tarang_taghvaei@yahoo.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