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NCT Number: NCT02289235

Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

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).

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Key information

Conditions

Fatty Liver Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ginger

Drug

Ginger powder capsule 1000 mg twice daily for 3 months

Placebo

Drug

Placebo powder 2 capsules twice daily for 3 months

Primary outcomes

  1. Change in ALT (liver transaminases) level

    Time frame: Baseline and 3 months

    Change in the concentration of ALT (liver transaminases)

  2. Change in score of fatty liver in fibroscan

    Time frame: Baseline and 3 months

    Change in score of fatty liver in fibroscan (elastography)

Secondary outcomes

  1. Change in AST (liver transaminases) level

    Time frame: Baseline and 3 months

    Change in the concentration of AST (liver transaminases)

  2. Change in Gama GT (γ-glutamyl transpeptidase) levels

    Time frame: Baseline and 3 months

    Change in the concentration of Gama GT (γ-glutamyl transpeptidase)

  3. Number of patients with adverse events

    Time frame: 4 months

    Number of patients with adverse events

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)

Acronym: GinLivDM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2014
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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