Non-alcoholic Fatty Liver DiseasePhase 2/3NCT02535195
Effect of Ginger Supplement on Non-alcoholic Fatty Liver
A Phase 2/3 study testing Ginger supplement in people with Non-alcoholic Fatty Liver Disease, run by Dr Azita Hekmatdoost.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Ginger supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of steatosis on ultrasound examination
- high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Ginger supplement, Placebo (starch)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger supplementDietary supplement
Placebo (starch)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Active comparator | 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. Receives: Dietary Supplement: Ginger supplement |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo (starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of the ALT liver enzyme
Measured: 12 weeks
Serum levels of the AST liver enzyme
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Azita Hekmatdoost
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535195
- Sponsor's protocol ID
- 93-03-161-27265
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2015
- Last updated
- 28 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ginger Supplement on Non-alcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT02535195
- Acronym / sponsor ID
- 93-03-161-27265
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr Azita HekmatdoostUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Active comparator | Dietary Supplement: Ginger supplementParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (starch)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of steatosis on ultrasound examination
- high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)
Key exclusion criteria (10 listed)
- various types of hepatitis
- diabetes mellitus
- cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others)
- non-treated hypothyroidism
- using alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger supplement | Dietary supplement | Ginger |
| Placebo (starch) | Dietary supplement | Placebo |
Primary outcome
Serum levels of the ALT liver enzyme
Time frame: 12 weeks
Serum levels of the AST liver enzyme
Time frame: 12 weeks
1 secondary outcome
controlled attenuation parameter(CAP) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginger supplement in people with Non-alcoholic Fatty Liver Disease, run by Dr Azita Hekmatdoost.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of the ALT liver enzyme (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2015.