The objective of this randomized triple blind controlled trial is to compare the effects of Doxepine and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 50 patients with IBS are randomly assigned to receive Doxepin or Nortriptyline, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903114017N3
Registration date:2010-06-12, 1389/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Hosseinali Habibinejad
Name of organization / entity
Islamic Azad University of Qom
Country
Iran (Islamic Republic of)
Phone
+98 21 7745 4051
Email address
ghadir@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Young Researchers Club
Expected recruitment start date
2010-06-04, 1389/03/14
Expected recruitment end date
2010-09-20, 1389/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative survey of the effect of doxepin and nortriptyline on diarrhea-predominant irritable bowel syndrome
Public title
Effect of doxepin and nortriptyline on irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of diarrhea predominant irritable bowel syndrome according to ROME criteria
Exclusion criteria: Gastrointestinal bleeding, More than 5% weight loss in the last 6 months, presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Saheli Ave., Qom
City
QOM
Postal code
Approval date
empty
Ethics committee reference number
263/د
Health conditions studied
1
Description of health condition studied
diarrhea predominant irritable bowel syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
abdominal pain
Timepoint
prior to intervention- 1 month after intervention- 2 month after intervention
Method of measurement
visual scale of pain
2
Description
mucus in the stool
Timepoint
prior to intervention- 1 month after intervention- 2 month after intervention
Method of measurement
visual scale of mucus in the stool
3
Description
Bloating
Timepoint
prior to intervention- 1 month after intervention- 2 month after intervention
Method of measurement
visual scale of bloating
4
Description
Incomplete evacuation
Timepoint
prior to intervention- 1 month after intervention- 2 month after intervention
Method of measurement
visual scale of Incomplete evacuation
Secondary outcomes
1
Description
somnolence
Timepoint
prior to intervention-1 month after intervention-2 months after intervention
Method of measurement
visual scale of somnolence
2
Description
constipation
Timepoint
prior to intervention-1 month after intervention-2 months after intervention
Method of measurement
visual scale of constipation
3
Description
urinary retention
Timepoint
prior to intervention-1 month after intervention-2 months after intervention
Method of measurement
visual scale of urinary retention
4
Description
tachycardia
Timepoint
prior to intervention-1 month after intervention-2 months after intervention
Method of measurement
pulse examination
Intervention groups
1
Description
Doxepin,tablet 10 mg oral,once daily for 2 months
Category
Treatment - Drugs
2
Description
Nortriptyline,tablet 10 mg oral,once daily for 2 months