Comparison of anti-anxiety drug therapy (duloxetine and sertraline) on anxiety and gastrointestinal symptoms in patients with irritable bowel syndrome
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 192 patients. Blocking method will be used for randomization.
Settings and conduct
This study is performed in Buali Gastroenterology Clinic and Valiasr Hospital in Birjand, South Khorasan Province. 192 patients are randomly divided into three groups receiving sertraline, duloxetine and antispasmodics. Patients' anxiety and clinical symptoms are assessed by the facilitator at the beginning and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between the age of 18 to 50 years; willingness to participate. Exclusion criteria: Non-cooperation of the patient; history of gastrointestinal cancer and neurological disorders; pregnancy and lactation; bipolar or bipolar patients; contraindications to the use of both Sertraline and duloxetine; the use of antidepressants and anti-anxiety drugs; allergies to prescription drugs; concomitant serious physical illnesses such as heart disease; multiple sclerosis; psychosis Like schizophrenia and related disorders; it will be substance abuse and substance abuse.
Intervention groups
Intervention groups include patients receiving sertraline 50 mg, dolextin 60 mg (manufactured by Obaidi Iran) or antispasmodic (135 mg by Alhawi Iran) and symptomatic treatment of diarrhea or constipation for one month. They receive daily.
Main outcome variables
Anxiety and clinical signs of patients include: bloating or abdominal distension, bowel movements in the form of diarrhea or constipation or diarrhea and constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210420051023N1
Registration date:2021-09-08, 1400/06/17
Registration timing:prospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Enayat Moghri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3242 2111
Email address
moghri1992@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2021-11-20, 1400/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anti-anxiety medication (Sertraline and Duloxetine) on anxiety and gasterointestinal symptoms of irritable bowel syndrome patients
Public title
Effects of Sertralin and Duloxetin in treatment of IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No receiving psychological therapies before entering the study
Not having other structural or functional gastrointestinal disorders at the same time
Not suffering from other organic diseases
Not having psychotic disorder and personality disorder
No risk symptoms such as gastrointestinal bleeding, blood in the stool, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn, etc.,
Exclusion criteria:
Consuming alcohol and substances abuse
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be randomly divided into three intervention groups: sertraline (A), Duloxetine (B) or antispasmodic, and symptomatic treatment of diarrhea or constipation (C) using the blocking method. First, various triple blocks are created using sealed envelopes (ABC, ACB, BAC, BCA, CAB, CBA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be allocated into one of three groups A, B or C. Then randomization will be performed for other patients in the same way.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Evaluator: The study facilitator (medical student) will perform the necessary evaluation without knowing the type of medication received by the patients and will be recorded in a checklist designed for this purpose.
Patients: The patients participating in the study are not aware of their group, so the drugs are packaged in the same package and given to patients by the pharmacy.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Moalem
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.BUMS.REC.1400.070
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Depression score in Beck questionnaire
Timepoint
First study and 30 days after the start of sertraline and duloxetine
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1 patients who are given sertraline 50 mg daily (Obidi Pharmaceutical Company made in Iran) for one month.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2 patients who are given duloxetine 60 mg daily (Obidi Pharmaceutical Company made in Iran) for one month.
Category
Treatment - Drugs
3
Description
Control group: Intervention group: 3 patients who are given antispasmodic medication daily (Moburin with a dose of 135 mg made by Alhawi Company of Iran) and symptomatic treatment of diarrhea or constipation for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali subspecialty clinic
Full name of responsible person
Tahmineh Tavakoli
Street address
Ghaffari
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3204 8321
Email
moghri1992@yahoo.com
2
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Valiasr Hospital_Birjand
Full name of responsible person
Enayat Moghri
Street address
Gastroenterology Clinic of Valiasr Hospital , Ghafari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3261 2001
Email
valiasr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Moallem Ave., Birjand University of Medical Sciences. Birjand Town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
moghri1992@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Enayat Moghri
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moalem_Bozorgmehr
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3242 2111
Fax
+98 56 3204 8321
Email
Moghri1992@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Enayat Moghri
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moalem_bozorgmehr
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3242 2111
Fax
+98 56 3204 8321
Email
Moghri1992@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Enayat Moghri
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moalem_bozorgmehr
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3242 2111
Fax
+98 56 3204 8321
Email
Moghri1992@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of documents is permitted only for use in helping patients
From where data/document is obtainable
enayat moghri
What processes are involved for a request to access data/document
Submit a request for the use of documents or data files