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

Primary Purpose

Fatty Liver, Diabetes Mellitus, Type 2

Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ginger
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Ginger, Medicine, traditional, Herbal medicine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger

Placebo

Arm Description

Ginger powder capsule 500 mg

Placebo powder capsule

Outcomes

Primary Outcome Measures

Change in ALT (liver transaminases) level
Change in the concentration of ALT (liver transaminases)
Change in score of fatty liver in fibroscan
Change in score of fatty liver in fibroscan (elastography)

Secondary Outcome Measures

Change in AST (liver transaminases) level
Change in the concentration of AST (liver transaminases)
Change in Gama GT (γ-glutamyl transpeptidase) levels
Change in the concentration of Gama GT (γ-glutamyl transpeptidase)
Number of patients with adverse events
Number of patients with adverse events

Full Information

First Posted
November 7, 2014
Last Updated
October 17, 2020
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02289235
Brief Title
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Diabetes Mellitus, Type 2
Keywords
Ginger, Medicine, traditional, Herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger
Arm Type
Experimental
Arm Description
Ginger powder capsule 500 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder capsule
Intervention Type
Drug
Intervention Name(s)
Ginger
Intervention Description
Ginger powder capsule 1000 mg twice daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo powder 2 capsules twice daily for 3 months
Primary Outcome Measure Information:
Title
Change in ALT (liver transaminases) level
Description
Change in the concentration of ALT (liver transaminases)
Time Frame
Baseline and 3 months
Title
Change in score of fatty liver in fibroscan
Description
Change in score of fatty liver in fibroscan (elastography)
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in AST (liver transaminases) level
Description
Change in the concentration of AST (liver transaminases)
Time Frame
Baseline and 3 months
Title
Change in Gama GT (γ-glutamyl transpeptidase) levels
Description
Change in the concentration of Gama GT (γ-glutamyl transpeptidase)
Time Frame
Baseline and 3 months
Title
Number of patients with adverse events
Description
Number of patients with adverse events
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, M.D.
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Majid Nimruzi, M.D.
Organizational Affiliation
Research Center for Traditional Medicine, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamran Bagheri Lankarani, M.D.
Organizational Affiliation
Health policy Research Center, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Parisa-sadaat Ghoreishi, M.D.
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM

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