Clinical trial NCT02289235: Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fatty Liver
Diabetes Mellitus, Type 2
Keywords: Ginger
Medicine, traditional
Herbal medicine
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in ALT (liver transaminases) level
timeFrame: Baseline and 3 months
measure: Change in score of fatty liver in fibroscan
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in AST (liver transaminases) level
timeFrame: Baseline and 3 months
measure: Change in Gama GT (γ-glutamyl transpeptidase) levels
timeFrame: Baseline and 3 months
measure: Number of patients with adverse events
timeFrame: 4 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Mesbah Shams, M.D.
role: STUDY_CHAIR
affiliation: Research Center for Traditional Medicine, Shiraz University of Medical Sciences
name: Majid Nimruzi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health policy Research Center, Shiraz University of Medical Sciences
name: Kamran Bagheri Lankarani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Parisa-sadaat Ghoreishi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: