Non-Alcoholic Fatty Liver DiseaseNAFLDNCT04049396
Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)
A study testing Berberine in people with Non-Alcoholic Fatty Liver Disease, run by Lida Nejati at 1 site in Iran.
Trial summary
Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Berberine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2018to 15 Jun 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have an age range between 18 to 65 years(inclusive).
- Patients with Liver fat content assessed by MRS≥13%.
- Patients must meet the criteria for impaired glucose regulation
- Course of diabetic mellitus less than 1 year
- Informed consent signed
Who cannot join
- Any causes of chronic liver disease other than NAFLD(such as-but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);
- Patients with significantly impaired liver function: ALT or AST≥2 times upper limit of normal;
- Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes;
- Course of diabetes more than 1 years;
- Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;
- Diabetics patients with a HbA1c>7.5% on initial visit;
Show all 18Show fewer
- Patients with severe diabetes complications(diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney);
- Patients with a history of clinically significant heart disease(myocardial infarct, heart failure, and/or severe cardiac rhythm);
- Complicating severe infection,within 6 months after operation, severe trauma;
- Patients with excess alcohol consumption≥140g/week(male); ≥70g/week(female);
- Patients have participated other clinical trials within 24 weeks;
- Patients with a history of drug allergy to berberine;
- Patients with gestation or possible gestation or lactation, or males or females expecting gestation during clinical trial;
- Mental diseases patients;
- Those who refuse to sign informed consent;
- Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study;
- Patients with serum triglyceride≥5.0mmol/L;
- Patients with thyroid disease, including hyperthyroidism or hypothyroidism.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Sciences & Research Branch,Azad University of Tehran
Tehran, 1477893855
About this study
Official title: The Effect of Berberine on Lipid Profile, Liver Enzymes and Fasting Blood Glucose in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses. The disease is associated with a group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity, hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver function and metabolic profiles of patients with NAFLD. In this context,A six week, open-label randomized controlled trial was conducted in a single medical center at Takestan Hospital, Iran. A total of 281 patients with NAFLD were enrolled and randomly assigned to treatment arm with (n=24) or without (n=24) berberine. All patients had received pre-randomization lifestyle training including recommendations on low-fat diet. Blood examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the beginning of the study and upon the completion of the trial (day 45). To assess tolerability of the study intervention and any possible adverse events, patients in both groups were required to attend weekly follow-up visits.
Read the detailed description
A seven-week (45-day), open-label, randomized controlled trial was conducted in a medical center affiliated with the Ministry of Welfare and Social Security in Iran to study the impact of berberine on liver function and metabolic profiles of patients with NAFLD. Hospital employees who met the enrollment criteria were identified through electronic health records (EHRs) available in a human resource database of employee routine annual examinations. Using a computer-generated random-allocation sequence, eligible employees were equally assigned (1:1) to berberine 6.25 g per day (arm A) or no intervention (Arm B). Berberine was administered orally (100 g dried berberine in 5 Liter water boiled at 167°F until 4Liter).). To control the potential impact of confounders on outcome measures, and to balance the daily dietary and physical activity among the study groups, all participants were trained by skilled experts on lifestyle and behavior improvement.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Berberine
- Keywords
- NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL
- 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.
BerberineOther
24 Patient consumed 6,25 g/day Berberine for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Berberine | Experimental | Berberine (6.25 g/day) Receives: Other: Berberine |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Alanine Aminotransferase (ALT)
Serum Alanine Aminotransferase concentration (units per liter)
Measured: Baseline and 6 weeks after
Change from baseline of Aspartate Aminotransferase (AST)
Serum Aspartate Aminotransferase concentration(units per liter)
Measured: Baseline and 6 weeks after
Change from baseline of Alkaline Phosphatase( ALP)
Serum Alkaline Phosphatase concentration (units per liter)
Measured: Baseline and 6 weeks after
Secondary outcomes (5)
Change from baseline of fasting blood sugar(FBS)
Fasting blood sugar concentration (mg/dl)
Measured: Baseline and 6 weeks after
Change from baseline of total cholesterol (TC)
Serum total cholesterol concentration (mg/dl)
Measured: Baseline and 6 weeks after
Change from baseline of LDL-Cholesterol
Serum LDL-Cholesterol concentration (mg/dl)
Measured: Baseline and 6 weeks after
Change from baseline of HDL - Cholesterol
Serum HDL-Cholesterol concentration (mg/dl)
Measured: Baseline and 6 weeks after
Change from baseline of Triglyceride (TG)
Serum Triglyceride concentration (mg/dl)
Measured: Baseline and 6 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Oct 2018
- Primary completion25 Mar 2019
- Study completion15 Jun 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study , samples were randomly divided into two groups receiving and not receiving supplement
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lida Nejati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lida Nejati, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049396
- Sponsor's protocol ID
- IR.IAU.SRB.REC
- Acronym
- NAFLD
- Status last verified
- Aug 2019
- First submitted
- 21 Jul 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berberine on Lipid Profile, Liver Enzymes and Fasting Blood Glucose in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04049396
- Acronym / sponsor ID
- NAFLD / IR.IAU.SRB.REC
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lida NejatiUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- 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.
Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses. The disease is associated with a group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity, hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver function and metabolic profiles of patients with NAFLD. In this context,A six week, open-label randomized controlled trial was conducted in a single medical center at Takestan Hospital, Iran. A total of 281 patients with NAFLD were enrolled and randomly assigned to treatment arm with (n=24) or without (n=24) berberine. All patients had received pre-randomization lifestyle training including recommendations on low-fat diet. Blood examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the beginning of the study and upon the completion of the trial (day 45). To assess tolerability of the study intervention and any possible adverse events, patients in both groups were required to attend weekly follow-up visits.
Detailed description
A seven-week (45-day), open-label, randomized controlled trial was conducted in a medical center affiliated with the Ministry of Welfare and Social Security in Iran to study the impact of berberine on liver function and metabolic profiles of patients with NAFLD. Hospital employees who met the enrollment criteria were identified through electronic health records (EHRs) available in a human resource database of employee routine annual examinations. Using a computer-generated random-allocation sequence, eligible employees were equally assigned (1:1) to berberine 6.25 g per day (arm A) or no intervention (Arm B). Berberine was administered orally (100 g dried berberine in 5 Liter water boiled at 167°F until 4Liter).). To control the potential impact of confounders on outcome measures, and to balance the daily dietary and physical activity among the study groups, all participants were trained by skilled experts on lifestyle and behavior improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study , samples were randomly divided into two groups receiving and not receiving supplement
| Arm | Type | Receives |
|---|---|---|
| Berberine | Experimental | Other: BerberineBerberine (6.25 g/day) |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have an age range between 18 to 65 years(inclusive).
- Patients with Liver fat content assessed by MRS≥13%.
- Patients must meet the criteria for impaired glucose regulation
- Course of diabetic mellitus less than 1 year
- Informed consent signed
Key exclusion criteria (18 listed)
- Any causes of chronic liver disease other than NAFLD(such as-but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);
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 |
|---|---|---|
| Berberine24 Patient consumed 6,25 g/day Berberine for 6 weeks | Other | Berberine |
Primary outcome
Change from baseline of Alanine Aminotransferase (ALT)
Time frame: Baseline and 6 weeks after
Serum Alanine Aminotransferase concentration (units per liter)
Change from baseline of Aspartate Aminotransferase (AST)
Time frame: Baseline and 6 weeks after
Serum Aspartate Aminotransferase concentration(units per liter)
Change from baseline of Alkaline Phosphatase( ALP)
Time frame: Baseline and 6 weeks after
Serum Alkaline Phosphatase concentration (units per liter)
5 secondary outcomes
Change from baseline of fasting blood sugar(FBS)
Time frame: Baseline and 6 weeks after
Change from baseline of total cholesterol (TC)
Time frame: Baseline and 6 weeks after
Change from baseline of LDL-Cholesterol
Time frame: Baseline and 6 weeks after
Change from baseline of HDL - Cholesterol
Time frame: Baseline and 6 weeks after
Change from baseline of Triglyceride (TG)
Time frame: Baseline and 6 weeks after
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 8 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Non-Alcoholic Fatty Liver Disease, run by Lida Nejati 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 18 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 8 Aug 2019. 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.
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 from baseline of Alanine Aminotransferase (ALT) (time frame: Baseline and 6 weeks after). The study lists 3 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 8 Aug 2019.