Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02289235
Recruitment Status : Enrolling by invitation
First Posted : November 13, 2014
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, 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).

Condition or disease Intervention/treatment Phase
Fatty Liver Diabetes Mellitus, Type 2 Drug: Ginger Drug: Placebo Early Phase 1

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: Ginger
Ginger powder capsule 500 mg daily for 3 months
Drug: Ginger
Ginger powder capsule 500 mg daily for 3 months

Placebo Comparator: Placebo
Placebo powder 1 capsule daily for 3 months
Drug: Placebo
Placebo powder 1 capsule daily for 3 months




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289235


Locations
Layout table for location information
Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Mesbah Shams, MD, Associate professor of Internal Medicine & Endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02289235     History of Changes
Other Study ID Numbers: CT-P-9364-6254
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mesbah Shams, MD, Shiraz University of Medical Sciences:
Ginger
Medicine, traditional
Herbal medicine

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Liver Diseases
Diabetes Mellitus, Type 2
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases