The effect of mesalazine and nortriptyline in patients with irritable bowel syndrome with diarrhea: A randomized clinical trail

The effect of mesalazine and nortriptyline on improvement of severity and frequency of abdominal pain and stool frequency recorded daily in patients with irritable bowel syndrome with diarrhea: A randomized clinical trail

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201506171647N4

Enrollment

Registered

2015-07-13

Start date

2012-08-10

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 with diarrhoea

Interventions

Intervention 1: Intervention group: mesalazine, tablet 500 mg oral, twice daily for 8 weeks. mesalazine, Sobhandarou, tablet 500 mg, Iran. Intervention 2: Control group: Nortriptyline (Sobhan Darou, I

Treatment - Drugs

Intervention group: mesalazine, tablet 500 mg oral, twice daily for 8 weeks. mesalazine, Sobhandarou, tablet 500 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 diarrhea predominant irritable bowel syndrome according to ROME III criteria. 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; history of malignancy; use of illicit drugs; patients with constipation and mixed predominant irritable bowel syndrome.

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.;Frequency of abdominal pain. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring).;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).;Frequency of bowel habit. 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.;Frequency of abdominal pain. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring).;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).;Frequency of bowel habit. 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