Effect Agomelatine versus placebo on irritable bowel syndrome associated with diarrhea

Effect Agomelatine versus placebo on irritable bowel syndrome associated with diarrhea: a double -blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N544

Enrollment

Registered

2024-11-30

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-01-08

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: Routine treatment plus agomelatine tablets 25 mg every night 8 weeks. Intervention 2: Control group:Routine treatment plus placebo tablets (starch) every night 8 we

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years Irritable bowel syndrome with diarrhea

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Use of antidepressants and anti-anxiety medications in the last month Use of anti-diarrheal medications in the last week Gastrointestinal surgery except appendectomy Chronic diseases such as diabetes, cardiovascular, liver or kidney failure Psychiatric illness

Design outcomes

Primary

Measure	Time frame
Clinical symptom severity. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS).;Quality of life. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using Quality of Life Questionnaire for Irritable Bowel Syndrome (IBS-QOL-34).;Stool quality and form. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Bristol Stool Form Scale (BSFS).;Anxiety disorder and depression. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Hospital Anxiety and Depression Scale (HADS).	—

Measure

Time frame

Clinical symptom severity. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS).;Quality of life. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using Quality of Life Questionnaire for Irritable Bowel Syndrome (IBS-QOL-34).;Stool quality and form. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Bristol Stool Form Scale (BSFS).;Anxiety disorder and depression. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Hospital Anxiety and Depression Scale (HADS).

—

Secondary

Measure	Time frame
Side effects (dizziness, itching, drowsiness). Timepoint: 8 weeks after the intervention. Method of measurement: By taking a history.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYasamin Taghavi

Hamedan University of Medical Sciences

jas.taghavi@gmail.com+98 81 3838 0572

Outcome results

None listed

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