Comparison of the Efficacy of Escitalopram, Venlafaxine and Buspirone on the Symptoms and Quality of Life in Irritable Bowel Syndrome Patients
Design
Clinical trial with parallel groups, single blind and randomized on 90 patients
Settings and conduct
Three groups of 30 patients with irritable bowel syndrome will be treated with one of the three escitalopram, venlafaxin or buspirone drugs for 8 weeks in three parallel groups. Medications are given in capsule form and patients do not know what type of drug they are taking.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of irritable bowel syndrome; Patient's written consent to participate in the study
Exclusion Criteria: Age less than 18 years; Allergies to citalopram, venlafaxin or buspirone; The presence of warning signs such as chronic fever, weight loss, gastrointestinal bleeding; pregnancy and lactation; The use of any medication that can affect the bowel function (such as laxatives, antidiarrhea, antibiotics and probiotics) within one month before entering the study; Known cases of lactose intolerance; Severe physical illnesses, mental retardation, dementia, psychosis, and the existence of serious suicidal ideation and substance dependence that affects patients' compliance with the study protocol
Intervention groups
Intervention group 1: Daily 10-20 milligram of Escitalopram manufactured in Sobhan Pharmaceutical Company for eight weeks
Intervention group 2: 75-375 milligram of Venlafaxine manufactured in Abidi Pharmaceutical Company for eight weeks
Intervention group 3: Daily 15-60 milligram of Buspirone manufactured in Sobhan Pharmaceutical Company for eight weeks
Main outcome variables
Irritable bowel syndrome symptoms; Patient's quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N10
Registration date:2018-03-21, 1397/01/01
Registration timing:registered_while_recruiting
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
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
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Escitalopram, Venlafaxine and Buspirone on the Symptoms and Quality of Life in Irritable Bowel Syndrome Patients
Public title
Efficacy of Escitalopram, Venlafaxine and Buspirone in Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Presence of ROME-III Diagnostic Criteria for Diagnosis of Irritable Bowel Syndrome
To Provide the Informed Consent Form of the Patient for Participation in the Study
Exclusion criteria:
Age under 18 years
Allergy to Escitalopram, Venlafaxine or Buspirone
The presence of warning signs such as chronic fever, weight loss, gastrointestinal bleeding
Pregnancy and breast feeding
Use of any drug that can affect the bowel function (such as laxatives, anti-diarrhea, antibiotics and probiotics) within one month before entering the study
Known cases of lactose intolerance
Severe physical illnesses, mental retardation, dementia, psychosis, and the existence of serious suicidal ideation and substance dependence that affects patients' compliance with the study protocol
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The individuals are randomly assigned to one of the three study groups with the help of a random number table and receive the intervention of the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In each of the three study groups, the drug is delivered to the patient in the form of a capsule, and the patient does not know what type of drug is used.
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
2017-10-15, 1396/07/23
Ethics committee reference number
MUBABOL.REC.1396.70
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
Irritable bowel syndrome symptoms
Timepoint
Baseline assessment and at the end of the eighth week of intervention
Method of measurement
According to ROME-III diagnostic criteria
2
Description
Patient´s quality of life
Timepoint
Baseline assessment and at the end of the eighth week of intervention
Method of measurement
According to the quality of life questionnaire IBS_QOL
Secondary outcomes
1
Description
The drug side effects
Timepoint
At the fourth and eighth weeks of the intervention
Method of measurement
Visit of the patient
Intervention groups
1
Description
Intervention group 1: Daily 10-20 milligram Escitalopram manufactured in Sobhan Pharmaceutical Company for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Daily 75-375 milligram Venlafaxine manufactured in Abidi Pharmaceutical Company for 8 weeks
Category
Treatment - Drugs
3
Description
Control group: Daily 15-60 milligram Buspirone manufactured in Sobhan Pharmaceutical Company for 8 weeks