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NCT02535195 Clinical Trial

Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Non-alcoholic Fatty Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02535195
Other study ID # 93-03-161-27265
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 24, 2015
Last updated August 26, 2015
Start date March 2013
Est. completion date August 2015

Study information
Verified date August 2015
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority Iran:Tehran, Amir Abad, Keshavarz Boulevard
Study type Interventional

Clinical Trial Summary

The hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2015
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- presence of steatosis on ultrasound examination

- high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)

Exclusion Criteria:

- various types of hepatitis

- diabetes mellitus

- cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others)

- non-treated hypothyroidism

- using alcohol

- consumption of phenytoin amoxyfan and lithium

- using minerals multivitamin supplements such as vitamin E, vitamin D, supplements made from Silybum marianum extract like livergol

- weight loss surgery in the last year or strict diets to weight loss in the past three months pregnancy

- lactation

- autoimmune diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ginger supplement

• Placebo (starch)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dr Azita Hekmatdoost

Outcome
Type Measure Description Time frame Safety issue
Primary Serum levels of the ALT liver enzyme 12 weeks Yes
Primary Serum levels of the AST liver enzyme 12 weeks Yes
Secondary controlled attenuation parameter(CAP) score controlled attenuation parameter(CAP) score is a novel measurement for evaluation of hepatic steatosis and it evaluated in dB/m at 3.5 MHz by M probe. normal range is 100- 140 dB/M. 12 weeks Yes
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