Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM (GinLivDM)

Shiraz University of Medical Sciences

Status and phase

Completed

Early Phase 1

Conditions

Fatty Liver

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Ginger

Study type

Interventional

Funder types

Other

Identifiers

NCT02289235

CT-P-9364-6254

Details and patient eligibility

About

The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Full description

Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.

In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Enrollment

76 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Controlled type 2 diabetes mellitus (HbA1c<7%)
Age: 20-65 years
Body mass index: 18-35 kg/m2
Serum ALT level: >60 U/Lit. in males, >38 U/Lit. in females
Grade >=2 fatty liver in liver sonography

Exclusion criteria

Pregnancy
Acute or chronic liver failure
Acute or chronic renal failure
Autoimmune or viral hepatitis
Wilson's disease
Alcoholism
Malignancy
Hypothyroidism or hyperthyroidism
Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.