Effect of sertraline and nortriptyline on irritable bowel syndrome: A randomized clinical trail

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201504131647N3

Enrollment

Registered

2015-06-11

Start date

2012-08-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: 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. Intervention 2: Control group: Nor

Treatment - Drugs

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.

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.;Interference with quality of life. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring).	—

Measure

Time frame

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.;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.;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.;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.;Interference with quality of life. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring).

—

Secondary

Measure	Time frame
Bloating. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: IBS, Adequate Relief (IBS, AR).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hamid Vahedi

Shahroud University of Medical Sciences

a.khosravi@shmu.ac.ir+98 23 3239 1850

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026