Evaluation of the efficacy of sertraline on symptoms and quality of life in patients with irritable bowel syndrome
Design
Randomized clinical trial with control group, with parallel groups
Settings and conduct
Sixty patients with irritable bowel syndrome after a clinical diagnosis by a gastroenterologist will be referred to a psychiatrist, in order to assess the presence of comorbid psychiatric disorders through a clinical structured psychiatric interview. Then, the patients will be randomly allocated in the two case and control groups in the absence of exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The presence of ROME III diagnostic criteria for the diagnosis of irritable bowel syndrome; Written consent for participation in the study
Exclusion criteria: Age under 18 years; The presence of warning signs such as chronic fever, weight loss, gastrointestinal bleeding; Use of any drug that affects the bowel function (such as laxatives, anti diarrhea and antibiotics) within one month before entering the study; Known cases of lactose intolerance; Comorbidity of other serious physical or psychological illnesses, serious suicidal thoughts and substance dependence that affect the treatment of patients and their compliance with the study protocol
Intervention groups
Intervention group: Daily 50-200 milligram Sertraline manufactured in Doctor Abidi Pharmaceutical Company and 200 milligram Clofac (Mebeverine Hydrochloride) each night for 8 weeks
Control group: 200 milligram Clofac (Mebeverine Hydrochloride) each night for 8 weeks
Main outcome variables
Severity of irritable bowel syndrome symptoms; The patients quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N11
Registration date:2018-03-22, 1397/01/02
Registration timing:registered_while_recruiting
Last update:2018-03-22, 1397/01/02
Update count:0
Registration date
2018-03-22, 1397/01/02
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Sertraline on the Symptoms and Quality of Life in Irritable Bowel Syndrome Patients
Public title
Efficacy of Sertraline in Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of ROME III diagnostic criteria for the diagnosis of irritable bowel syndrome
Written consent for participation in the study
Exclusion criteria:
Age under 18 years
Allergy to sertraline
The presence of warning signs such as chronic fever, weight loss, gastrointestinal bleeding
Pregnancy and breast feeding
Use of any drug that affects the bowel function (such as laxatives, anti diarrhea and antibiotics) within one month before entering the study
Known cases of lactose intolerance
Comorbidity of other serious physical or psychological illnesses, serious suicidal thoughts and substance dependence that affect the treatment of patients and their compliance with the study protocol
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation
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 Babol University of Medical Sciences
Street address
Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
MUBABOL.HRI.REC.1396.52
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
Severity of irritable bowel syndrome symptoms
Timepoint
At baseline, and the fourth and eighth weeks after the intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
The patients quality of life
Timepoint
At baseline, and the eighth week after the intervention
Method of measurement
SF-36 quality of life questionnaire
Secondary outcomes
1
Description
Adverse drug side effects
Timepoint
The fourth and eighth weeks after the intervention
Method of measurement
Medical visit
Intervention groups
1
Description
Intervention group: Daily 50-200 milligram Sertraline manufactured in Doctor Abidi Pharmaceutical Company and 200 milligram Clofac for eight weeks
Category
Treatment - Drugs
2
Description
Control group: Daily 200 milligram Clofac for eight weeks