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

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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

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE November 13, 2014
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Change in ALT (liver transaminases) level [ Time Frame: Baseline and 3 months ]
    Change in the concentration of ALT (liver transaminases)
  • Change in score of fatty liver in fibroscan [ Time Frame: Baseline and 3 months ]
    Change in score of fatty liver in fibroscan (elastography)
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Change in ALT (liver transaminases) level [ Time Frame: 3 months ]
  • Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT02289235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Change in AST (liver transaminases) level [ Time Frame: Baseline and 3 months ]
    Change in the concentration of AST (liver transaminases)
  • Change in Gama GT (γ-glutamyl transpeptidase) levels [ Time Frame: Baseline and 3 months ]
    Change in the concentration of Gama GT (γ-glutamyl transpeptidase)
  • Number of patients with adverse events [ Time Frame: 4 months ]
    Number of patients with adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Change in AST (liver transaminases) level [ Time Frame: 3 months ]
  • Change in Gama GT (γ-glutamyl transpeptidase) levels [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
Official Title  ICMJE The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fatty Liver
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Ginger
    Ginger powder capsule 500 mg daily for 3 months
  • Drug: Placebo
    Placebo powder 1 capsule daily for 3 months
Study Arms  ICMJE
  • Experimental: Ginger
    Ginger powder capsule 500 mg daily for 3 months
    Intervention: Drug: Ginger
  • Placebo Comparator: Placebo
    Placebo powder 1 capsule daily for 3 months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 12, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02289235
Other Study ID Numbers  ICMJE CT-P-9364-6254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mesbah Shams, MD, Shiraz University of Medical Sciences
Study Sponsor  ICMJE Shiraz University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Shiraz University of Medical Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP