Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

Diabetes Mellitus, Type 2 Clinical Trial

— GinLivDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289235
• Other study ID #: CT-P-9364-6254
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: October 2020
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Ginger
Ginger powder capsule 1000 mg twice daily for 3 months
• Placebo
Placebo powder 2 capsules twice daily for 3 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ALT (liver transaminases) level	Change in the concentration of ALT (liver transaminases)	Baseline and 3 months
Primary	Change in score of fatty liver in fibroscan	Change in score of fatty liver in fibroscan (elastography)	Baseline and 3 months
Secondary	Change in AST (liver transaminases) level	Change in the concentration of AST (liver transaminases)	Baseline and 3 months
Secondary	Change in Gama GT (?-glutamyl transpeptidase) levels	Change in the concentration of Gama GT (?-glutamyl transpeptidase)	Baseline and 3 months
Secondary	Number of patients with adverse events	Number of patients with adverse events	4 months