The therapeutic effect of Melatonin, Metformin and Vitamin E in patients with non-alcoholic fatty liver disease

Compare the therapeutic effect of Melatonin, Metformin and Vitamin E on liver function, sugar and lipid factors in patients with non-alcoholic fatty liver disease (NAFLD) dietary regimen

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016040318124N3

Enrollment

Registered

2017-04-28

Start date

2015-12-22

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]. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Administration of melatonin (10 mg tablet) once a day with diet for a period of 3 months. Intervention 2: Administration of metformin (500 mg tablet) once a day with diet for a period

Treatment - Drugs

Administration of melatonin (10 mg tablet) once a day with diet for a period of 3 months

Administration of metformin (500 mg tablet) once a day with diet for a period of 3 months

Administration of vitamin E (800 IU tablet) once a day with diet for a period of 3 months

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having non-alcoholic fatty liver disease (NAFLD) without other liver diseases. Exclusion criteria: Alcohol consumption of more than 20 gr per day for women or more than 30 gr in men for at least 3 consecutive months during a recent 5 year period, Patients with autoimmune hepatitis, hepatitis B, hepatitis C and other chronic liver diseases, Patients with heart failure (New York Heart Association class II to IV), Patients taking drugs that cause osteo-hepatitis like fibrates, statins, NSAID, Amiodarone, and Tamoxifen, Patients with proven diabetes mellitus under medical therapy, Patients receiving vitamin C, zinc and selenium or antioxidant agents during a recent three months, Patients with kidney disease and kidney failure or any patients with GFR less than 60.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Liver function tests. Timepoint: Before treatment and 3 months later. Method of measurement: blood sample.	—

Secondary

Measure	Time frame
Lipid tests. Timepoint: Before treatment and 3 months later. Method of measurement: blood sample.;Sugar tests. Timepoint: Before treatment and 3 months later. Method of measurement: blood sample.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sina Khajeh Jahromi

Qazvin university of medical sciences

sina.khajehjahromi@gmail.com+98 28 3333 7006

Outcome results

None listed

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