Fatty LiverEarly Phase 1GinLivDMNCT02289235
Effects of Ginger on Nonalcoholic Fatty Liver Disease in T2DM
A Early Phase 1 study testing Ginger in people with Fatty Liver and Diabetes Mellitus, Type 2, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatty Liver, Diabetes Mellitus, Type 2
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2019to 1 Feb 2020
- Phase
- Early Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Controlled type 2 diabetes mellitus (HbA1c<7%)
- Age: 20-65 years
- Body mass index: 18-35 kg/m2
- Serum ALT level: >60 U/Lit. in males, >38 U/Lit. in females
- Grade >=2 fatty liver in liver sonography
Who cannot join
- Pregnancy
- Acute or chronic liver failure
- Acute or chronic renal failure
- Autoimmune or viral hepatitis
- Wilson's disease
- Alcoholism
Show all 9Show fewer
- Malignancy
- Hypothyroidism or hyperthyroidism
- Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
About this study
Official title: The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)
The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.
In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
- Conditions
- Fatty Liver, Diabetes Mellitus, Type 2
- Being tested
- Ginger, Placebo
- Keywords
- Ginger, Medicine, traditional, Herbal medicine
- Medical subject headings
- Fatty Liver, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
Ginger powder capsule 1000 mg twice daily for 3 months
PlaceboDrug
Placebo powder 2 capsules twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Experimental | Ginger powder capsule 500 mg Receives: Drug: Ginger |
| Placebo | Placebo comparator | Placebo powder capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALT (liver transaminases) level
Change in the concentration of ALT (liver transaminases)
Measured: Baseline and 3 months
Change in score of fatty liver in fibroscan
Change in score of fatty liver in fibroscan (elastography)
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in AST (liver transaminases) level
Change in the concentration of AST (liver transaminases)
Measured: Baseline and 3 months
Change in Gama GT (γ-glutamyl transpeptidase) levels
Change in the concentration of Gama GT (γ-glutamyl transpeptidase)
Measured: Baseline and 3 months
Number of patients with adverse events
Number of patients with adverse events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start1 May 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Mesbah Shams, M.D., Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesMajid Nimruzi, M.D., Principal investigator, Research Center for Traditional Medicine, Shiraz University of Medical SciencesKamran Bagheri Lankarani, M.D., Principal investigator, Health policy Research Center, Shiraz University of Medical SciencesParisa-sadaat Ghoreishi, M.D., Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289235
- Sponsor's protocol ID
- CT-P-9364-6254
- Acronym
- GinLivDM
- Status last verified
- Oct 2020
- First submitted
- 7 Nov 2014
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02289235
- Acronym / sponsor ID
- GinLivDM / CT-P-9364-6254
- Conditions
- Fatty Liver, Diabetes Mellitus, Type 2
- Keywords
- Ginger, Medicine, traditional, Herbal medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 13 Nov 2014 (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 investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Detailed description
Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.
In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Drug: GingerGinger powder capsule 500 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo powder capsule |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Controlled type 2 diabetes mellitus (HbA1c<7%)
- Age: 20-65 years
- Body mass index: 18-35 kg/m2
- Serum ALT level: >60 U/Lit. in males, >38 U/Lit. in females
- Grade >=2 fatty liver in liver sonography
Key exclusion criteria (9 listed)
- Pregnancy
- Acute or chronic liver failure
- Acute or chronic renal failure
- Autoimmune or viral hepatitis
- Wilson's disease
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 |
|---|---|---|
| GingerGinger powder capsule 1000 mg twice daily for 3 months | Drug | Ginger |
| PlaceboPlacebo powder 2 capsules twice daily for 3 months | Drug | Placebo |
Primary outcome
Change in ALT (liver transaminases) level
Time frame: Baseline and 3 months
Change in the concentration of ALT (liver transaminases)
Change in score of fatty liver in fibroscan
Time frame: Baseline and 3 months
Change in score of fatty liver in fibroscan (elastography)
3 secondary outcomes
Change in AST (liver transaminases) level
Time frame: Baseline and 3 months
Change in Gama GT (γ-glutamyl transpeptidase) levels
Time frame: Baseline and 3 months
Number of patients with adverse events
Time frame: 4 months
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 20 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Mesbah Shams, M.D. study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Majid Nimruzi, M.D. principal investigator
Research Center for Traditional Medicine, Shiraz University of Medical Sciences
Kamran Bagheri Lankarani, M.D. principal investigator
Health policy Research Center, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ginger in people with Fatty Liver and Diabetes Mellitus, Type 2, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 9 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in ALT (liver transaminases) level (time frame: Baseline and 3 months). 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 20 Oct 2020.