Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Fatty Liver, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Ginger
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger<br>Ginger powder capsule 500 mg | Drug: Ginger<br>* Ginger powder capsule 1000 mg twice daily for 3 months<br>|
| Placebo Comparator: Placebo<br>Placebo powder capsule | Drug: Placebo<br>* Placebo powder 2 capsules twice daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ALT (liver transaminases) level | Change in the concentration of ALT (liver transaminases) | Baseline and 3 months | 
| Change in score of fatty liver in fibroscan | Change in score of fatty liver in fibroscan (elastography) | Baseline and 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginger, Medicine, traditional, Herbal medicine