Efficacy and Safety of Sublingual Melatonin in alleviation of irratable Bowel

Efficacy and Safety of Sublingual Melatonin in alleviation of IBS Symptoms

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121021011192N14

Enrollment

Registered

2023-05-29

Start date

2023-06-22

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Irritable Bowel Syndrom. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: Sublingual administration of 3 miligram of melatonin daily for 8 weeks. Intervention 2: Control group: Sublingual administration of melatonin placebo tablet daily f

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients above 18 years old with compliant of lower abdominal pain and changes in defecation more than three months obtaining consent form for entry the study

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women Patients with Kidney injury (AKIN classification stage 3)

Design outcomes

Primary

Measure	Time frame
Score of quality of life on the basis of IBS-QOL34. Timepoint: Before intervention and 4 weeks after initiation of use of melatonin. Method of measurement: QOL34 questionarre.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Abbasinazari

Shahid Beheshti University of Medical Sciences

m_abbasi@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

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