Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

Early Phase 1

Completed

• Conditions: Fatty Liver; Diabetes Mellitus, Type 2
• Interventions: Drug: Ginger; Drug: Placebo

• Registration Number: NCT02289235
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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).

Detailed 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).

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Study Start: 2019-05-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-17
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginger	Ginger	Ginger powder capsule 500 mg
Placebo	Placebo	Placebo powder capsule

Primary Outcome Measures

Name	Time	Method
Change in ALT (liver transaminases) level	Baseline and 3 months	Change in the concentration of ALT (liver transaminases)
Change in score of fatty liver in fibroscan	Baseline and 3 months	Change in score of fatty liver in fibroscan (elastography)

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	4 months	Number of patients with adverse events
Change in AST (liver transaminases) level	Baseline and 3 months	Change in the concentration of AST (liver transaminases)
Change in Gama GT (γ-glutamyl transpeptidase) levels	Baseline and 3 months	Change in the concentration of Gama GT (γ-glutamyl transpeptidase)

Trial Locations

Locations (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of