Non-alcoholic Fatty Liver DiseasePhase 2/3NCT02303314
Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
A Phase 2/3 study testing Trigonella Foenum-graecum Seed Extract in people with Non-alcoholic Fatty Liver Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Trigonella Foenum-graecum Seed Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIran
- Study dates
- Nov 2014to Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The level of ALT and AST greater than 1.5 and less than 10 times normal level
- Ultrasound evidence confirm fatty liver disease; age between 18-70 years old
- Negative pregnancy test for women in reproductive age (up to two weeks prior to the study)
- Negative for hepatitis B and C
- BMI: 18.5 to 40
- Sign the consent form.
Who cannot join
- History of more than one unit of alcohol consumption (one value for the Spirits (vodka; whiskey)
- Wine and Beer are respectively 30-45 cc; 120-150 cc and 360 cc.)
- Fatty liver controller medications
- Glucose lowering drugs
- Cholesterol lowering drugs
- Hypotensive drugs
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- Consumption of vitamin E
- Taking coenzyme Q10
- Administration of corticosteroids \& glucocorticoids
- Thyroxin administration
- Administration of drugs that cause fatty liver
- Diabetes (type 1 and 2)
- History of cancer in the past
- Hepatocellular carcinoma
- Renal failure (creatinine> 1.5 x ULN)
- Chronic pancreatitis
- Cirrhosis
- Uncontrolled hypertension (above 180 mm Hg systolic blood pressure); heart disease
- Autoimmune hepatitis
- Primary biliary cirrhosis
- Primary sclerosing cholangitis (alkaline phosphatase levels greater than 3 times normal)
- Wilson's disease
- Alpha-1 antitrypsin deficiency and coronary artery disease
- Symptoms of hypothyroidism
- Hyperthyroidism
- Disorders of the hypothalamic - pituitary
- Liver transplantation
- Pregnant or lactating women
- Those who cannot use contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively.
Read the detailed description
This study design to examine performance of trigonella foenum-graecum in treatment of non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty liver disease include in study. Patients with alcohol consumption, other liver disease and taking medications that cause liver injury, exclude. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Control group, in addition to diet and exercise recommendations take placebo capsules for 3 months. Intervention group, in addition to diet and exercise recommendations, use capsules containing hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan and the person analyzing the data are blind to group drugs.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Trigonella Foenum-graecum Seed Extract, Drug: Placebo
- 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.
Trigonella Foenum-graecum Seed ExtractDrug
Drug: PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Drug: Trigonella Foenum-graecum | Other | in this group patients use Trigonella Foenum-graecum seed extract twice daily. Receives: Drug: Trigonella Foenum-graecum Seed Extract |
| Drug: Placebo | Other | in this group patients use placebo twice daily. Receives: Drug: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness change
Assessment by Fibroscan
Measured: At baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2017
- Study completionSep 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Hossein Babaei, Shiraz University of Medical Sciences
- Investigators
- Seyed Alireza Taghavi, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303314
- Sponsor's protocol ID
- CT-P-9362-6352
- Other IDs
- IRCT2013102015083N1, CT-P-9362-6352
- Status last verified
- Sep 2017
- First submitted
- 21 Nov 2014
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02303314
- Acronym / sponsor ID
- CT-P-9362-6352
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 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.
This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively.
Detailed description
This study design to examine performance of trigonella foenum-graecum in treatment of non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty liver disease include in study. Patients with alcohol consumption, other liver disease and taking medications that cause liver injury, exclude. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Control group, in addition to diet and exercise recommendations take placebo capsules for 3 months. Intervention group, in addition to diet and exercise recommendations, use capsules containing hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan and the person analyzing the data are blind to group drugs.
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 |
|---|---|---|
| Drug: Trigonella Foenum-graecum | Other | Drug: Trigonella Foenum-graecum Seed Extractin this group patients use Trigonella Foenum-graecum seed extract twice daily. |
| Drug: Placebo | Other | Drug: Drug: Placeboin this group patients use placebo twice daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The level of ALT and AST greater than 1.5 and less than 10 times normal level
- Ultrasound evidence confirm fatty liver disease; age between 18-70 years old
- Negative pregnancy test for women in reproductive age (up to two weeks prior to the study)
- Negative for hepatitis B and C
- BMI: 18.5 to 40
Key exclusion criteria (29 listed)
- History of more than one unit of alcohol consumption (one value for the Spirits (vodka; whiskey)
- Wine and Beer are respectively 30-45 cc; 120-150 cc and 360 cc.)
- Fatty liver controller medications
- Glucose lowering drugs
- Cholesterol lowering drugs
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 |
|---|---|---|
| Trigonella Foenum-graecum Seed Extract | Drug | Drug: Trigonella Foenum-graecum |
| Drug: Placebo | Drug | Drug: Placebo |
Primary outcome
Liver stiffness change
Time frame: At baseline and 12 weeks after intervention
Assessment by Fibroscan
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 25 Sep 2017.
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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.
Seyed Alireza Taghavi principal investigator
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 Phase 2/3 study testing Trigonella Foenum-graecum Seed Extract in people with Non-alcoholic Fatty Liver Disease, 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 6 inclusion and 29 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 25 Sep 2017. 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. 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?
Liver stiffness change (time frame: At baseline and 12 weeks after intervention). 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 25 Sep 2017.