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Investigating the effect of melatonin on the treatment of non-alcoholic steatohepatitis patients

Investigating the effect of melatonin on the treatment of non-alcoholic steatohepatitis patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231002059591N2
Enrollment
60
Registered
2025-03-06
Start date
2025-04-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Non-alcoholic steatohepatitis. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group:Patients with NASH are given 6 mg of melatonin, manufactured by Galenus Company, at night before bed for 12 weeks. Intervention 2: Control group: Patients with NASH

Sponsors

Galenos pharmaceutical company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Evidence in favor of non-alcoholic steatohepatic disease with sonography AST>30 IN men AST>19 IN female

Exclusion criteria

Exclusion criteria: Autoimmune disease Liver and biliary disease heart disease Diabetes Mellitus kidney disease Metabolic disease malignancy Hypothyroidism Cushing syndrome History of hepatitis pregnancy alcohol consumption Fatty liver grade 1

Design outcomes

Primary

MeasureTime frame
Fatty liver grade. Timepoint: 12week. Method of measurement: liver sonography.

Secondary

MeasureTime frame
Level insulin. Timepoint: The beginning of the study- 12 week. Method of measurement: unit.;Aspartate aminotransferase. Timepoint: The beginning of the study- 12 week. Method of measurement: Milli-international units per litre.;Alanine aminotransferase. Timepoint: The beginning of the study- 12 week. Method of measurement: Milli-international units per litre.;Fatty liver stage. Timepoint: The beginning of the study- 12 week. Method of measurement: Based on ultrasound, no/1/2/3.;Fasting blood suger. Timepoint: The beginning of the study- 12 week. Method of measurement: Milligrams Per Deciliter.;Study group. Timepoint: The beginning of the study- 12 week. Method of measurement: Intervention/control.;Fibrosis-4 Index. Timepoint: The beginning of the study- 12 week. Method of measurement: The number according to the formula.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahareh Mahjoubi Asil

Zahedan University of Medical Sciences

info@zaums.ac.ir+98 54 3329 5574

Outcome results

None listed

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