Status:
COMPLETED
Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Lida Nejati
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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%....
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04049396
Start Date
October 1 2018
End Date
June 15 2019
Last Update
August 8 2019
Active Locations (1)
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1
Sciences & Research Branch,Azad University of Tehran
Tehran, Iran, 1477893855