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

October 17, 2020 updated by: Mesbah Shams, MD, Shiraz University of Medical Sciences

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of
        • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Mesbah Shams, M.D., Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Majid Nimruzi, M.D., Research Center for Traditional Medicine, Shiraz University of Medical Sciences
  • Principal Investigator: Kamran Bagheri Lankarani, M.D., Health Policy Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Parisa-sadaat Ghoreishi, M.D., shiraz University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 17, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P-9364-6254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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