Back to resultsEffect of Ginger Supplement on Non-alcoholic Fatty Liver
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ginger supplement
Placebo (starch)
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ginger
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Serum levels of the ALT liver enzyme
Serum levels of the AST liver enzyme
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02535195
Brief Title
Effect of Ginger Supplement on Non-alcoholic Fatty Liver
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Azita Hekmatdoost
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ginger
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (starch)
Primary Outcome Measure Information:
Title
Serum levels of the ALT liver enzyme
Time Frame
12 weeks
Title
Serum levels of the AST liver enzyme
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
controlled attenuation parameter(CAP) score
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Ginger Supplement on Non-alcoholic Fatty Liver
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