Effect of melatonin in irritable bowel syndrome

A Comparative Study on Efficacy and Safety of Melatonin as an Add on Therapy with Standard Treatment in Patients with Irritable Bowel Syndrome: A Randomised Open Labelled Prospective Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074953

Enrollment

Registered

2024-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: K582- Mixed irritable bowel syndrome

Interventions

Intervention1: Tablet Melatonin 3mg: Tablet Melatonin 3mg Once a day at night for 8 weeks Control Intervention1: Tablet Dicyclomine 10mg, Tablet loperamide, Capsule Bifilac: Tablet Dicyclomine 20mg 2

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed patients with irritable bowel syndrome according to ROME IV criteria

Exclusion criteria

Exclusion criteria: Pregnant and lactating females Known case of irritable bowel syndrome patients H/O diabetes, hypertension, jaundice, liver, kidney, heart diseases and endocrine disorders H/ O any abdominal surgery Patients already diagnosed with any organic gastrointestinal diseases Known H/O taking sedatives, antianxiety, antidepressant, antiepileptic and thyroid medications Night shift workers Patients with H/ O malignancy, Chemotherapy, radiotherapy

Design outcomes

Primary

Measure	Time frame
Improvement in IBS- Symptom Severity Score, Bristol stool scale for stool consistency and the Pittsburgh Sleep Quality Index (PSQI) for sleep qualityTimepoint: 8 Weeks	—

Secondary

Measure	Time frame
Assessment of SafetyTimepoint: 4 and 8 Weeks and 12 Weeks	—

Countries

India

Contacts

Public ContactDrBSharmila

Government Kilpauk Medical College, Chennai

drsharmilab@gmail.com9841270830

Outcome results

None listed

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