Saffron in irritable bowel syndrome patients

Saffron vs Fluoxetine in irritable bowel syndrome patients: A double – blind controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201509081556N81

Enrollment

Registered

2015-09-16

Start date

2015-09-23

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: Capsule Saffron 15mg/day as intervention group for 6 weeks. Intervention 2: Capsule Fluoxetine 20 mg/day for 6 weeks.

Treatment - Drugs

Capsule Saffron 15mg/day as intervention group for 6 weeks

Capsule Fluoxetine 20 mg/day for 6 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 18-65 years old; IBS diagnosis through ROME III criteria; moderate to severe symptoms through severity of symptom questionnaire. Exclusion criteria: diagnosis of any organic disease related to symptoms during the study; psychological disorders taking any other psychotropic drugs during 4 weeks before entering to the trial; history of taking fluoxetine for treatment of IBS in the past; presence of any contraindications for taking fluoxetine; low compliance; severe complications due to fluoxetine; pregnancy or breastfeeding at the beginning or during the trial.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of symptom. Timepoint: Baseline and weeks 2-4-6 after beginig of treatment. Method of measurement: IBS-SSS questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

S.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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