Comparison of therapeutic effect of Melatonin, Metformin and Ursodeoxycholic acid with placebo in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD)

Health impact of Melatonin, Metformin and Ursodeoxycholic acid in treatment of patients with Nonalcoholic Fatty Liver Disease (NAFLD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201407201155N21

Enrollment

120

Registered

2015-09-22

Start date

2015-06-09

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

Nonalcoholic Fatty Liver Disease (NAFLD). Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Intervention 1: Intervention group 1:Melatonin,10 milligram, one number, daily. Intervention 2: Intervention group 2: Tab Metformin, 500 milligram one number, every 12 hours. Intervention 3: Intervent

Treatment - Drugs

Placebo

Intervention group 1:Melatonin,10 milligram, one number, daily

Intervention group 2: Tab Metformin, 500 milligram one number, every 12 hours

Intervention group 3: Cap Ursodeoxycholic acid, 300 milligram, one number, daily

Control group: Tab Placebo, one number, daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with Nonalcoholic Fatty Liver Disease (NAFLD) have proven statuses by Fibro Scan. Exclusion criteria: Consumption more than 20 gram of alcohol per day for women or more than 30 gram in men for at least 3 consecutive months during five last years; patients with hepatitis B, C and other chronic liver diseases including autoimmune liver diseases; patients with heart failure according to the history and clinical signs; patients who take medication causing osteohepatitis such as Tamoxifen, Amiodarone; patients with established diabetes mellitus; patients with established hemochromatosis; dissatisfaction for participate in study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum levels of liver enzymes. Timepoint: initially and three months later. Method of measurement: Laboratory Kit.;Steatosis. Timepoint: initially and three months later. Method of measurement: using fibroscan.	—

Secondary

Measure	Time frame
Serum Lipids. Timepoint: Initially and three months later. Method of measurement: Laboratory Kit.;Body Mass Index. Timepoint: Initially and three months later. Method of measurement: with Seca Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Joukar

Gastrointestinal and Liver Disease Research Center

F_Jokar@gums.ac.ir+98 13133535116

Outcome results

None listed

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