Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Dr Azita Hekmatdoost

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Ginger supplement; Dietary Supplement: Placebo (starch)

Study type: Interventional

Funder types: Other

Identifiers

NCT02535195

93-03-161-27265

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Ginger

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ginger supplement

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo (starch)