1. Home
  2. Approved trials
  3. » فارسی

The effect of sertraline and nortriptyline on improvement of abdominal pain and distention in patients with irritable bowel syndrome: A randomized clinical trail

Protocol summary

Summary
Objectives: the objective of this trial is to compare the effects of Sertraline and Nortriptyline on irritable bowel syndrome patients for relief of abdominal pain. Design: a triple blind, randomized clinical trail. Setting and conduct: in this stuy, 30 patients with irritable bowels syndrome are randomly assigned to receive Sertraline or Nortriptyline. Before allocation, all patients were completed Beck questionnaire for screening of depression. Major Inclusion and Exclusion criteria: the main exclusion criteria were the use of analgesic drugs; pregnant women; breast feeding; patients with major depressive disorder (MDD) according to DSM-IV-TR; gastrointestinal bleeding; presence of any finding in favor of organic disorders in the lab tests; or organic disorder in colonoscopy of high risk patients. Intervention: Sertraline (tablet 25mg oral for 7 days and then 50 mg oral) as intervention and Nortriptyline (tablet 10 mg oral) for control group once daily for 8 weeks. Main outcome measures variables: abdominal pain, the IBS,Symptom Severity Scoring measure (IBS,SSS), which contains five 100 point scales, that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life, incomplete evacuation, and bloating are measured and compared between groups at the baseline and 8 weeks after the intervention.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201504131647N3
Registration date: 2015-06-11, 1394/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-11, 1394/03/21
Registrant information
Name
Ahmad Khosravi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4499
Email address
khosravi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2013-07-01, 1392/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sertraline and nortriptyline on improvement of abdominal pain and distention in patients with irritable bowel syndrome: A randomized clinical trail
Public title
Effect of sertraline and nortriptyline on irritable bowel syndrome: A randomized clinical trail
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of clinical findings of irritable bowel syndrome according to ROME II criteria; including abdominal pain or refferal pain at least 3 days in every months. Exclusion criteria: use of analgesic drugs; pregnant women; breast feeding; patients with major depressive disorder (MDD) according to DSM-IV-TR; gastrointestinal bleeding; presence of any finding in favor of organic disorders in the lab tests; or organic disorder in colonoscopy of high risk patients.
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study patients were allocated to A and B according to permuted block randomization method,with block size of 4. For preventing the selection bias we used a concealment method.the A and B sequences were put to a closed envelopes. After assignment the patients were introduced to drug store for receiving their treatments.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Hafte Tir Square, Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Postal code
3614773955
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
910-5

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 abdominal pain
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain

2

Description
severity of abdominal distension
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain

3

Description
frequency of abdominal pain
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain

4

Description
dissatisfaction with bowel habits
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain

5

Description
interference with quality of life
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
Questionnaire (IBS, Symptom Severity Scoring)

Secondary outcomes

1

Description
Bloating
Timepoint
prior to intervention and 8 weeks after intervention
Method of measurement
IBS, Adequate Relief (IBS, AR)

Intervention groups

1

Description
Intervention group: Sertraline, tablet 25mg oral for 7 days and then 50 mg oral, once daily for 8 weeks. Sertraline, Sobhandarou, tablet 50 mg, Iran.
Category
Treatment - Drugs

2

Description
Control group: Nortriptyline (Sobhan Darou, Iran), tablet 10 mg oral, once daily for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital and Khatamol anbiya Hospital
Full name of responsible person
Dr Hamid Vahedi
Street address
Hafte Tir Square, Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Hamid Vahedi
Street address
7 Tir Sq, Shahroud University of Medical Sciences
City
Shahroud
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Hamid Vahedi
Position
MD, gastroenterologist
Other areas of specialty/work
Street address
Hafte Tir Square, Central Building of Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
+98 23 3239 4800
Email
a.khosravi@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Hamid Vahedi
Position
gastroenterologist
Other areas of specialty/work
Street address
Hafte Tir Square, Central Building of Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
+98 23 3239 4800
Email
a.khosravi@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ahmad Khosravi
Position
PhD candidate of Epidemiology
Other areas of specialty/work
Street address
Hafte Tir Square, Central Building of Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
+98 23 3239 4800
Email
khosravi2000us@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...