Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ginger

Participants were randomly divided based on age, sex and severity of steatosis in two groups. Randomization lists were computer-generated by a statistician and participants, project managers and employees at the clinic were completely unaware (blind) about intervention and control groups. At the first visit, baseline data were gathered and patients advised to consume 2 capsules content 500 mg of ginger (made in Green Plants of Life Pharmaceutics Co., Iran) or placebo (starch) one hour after breakfast and two capsules after dinner for 3 weeks. Capsules was administrated for all patients in the first week for 3 weeks and in each visit new series of supplement was prescribed.

Group Type ACTIVE_COMPARATOR

Ginger supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 capsules content 500 mg of placebo(starch) (made in Green Plants of Life Pharmaceutics Co., Iran) one hour after breakfast and two capsules after dinner for 3 weeks. Capsules was administrated for all patients in the first week for 3 weeks and in each visit new series of supplement was prescribed.

Group Type PLACEBO_COMPARATOR

Placebo (starch)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ginger supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo (starch)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes