The effects of berberis integerrima extract on the non-alcoholic fatty liver disease (NAFLD)

The effects of berberis integerrima extract on liver enzymes, liver steatosis and fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) following the DASH diet: a double-blind randomized clinical trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210427051098N6

Enrollment

Registered

2024-02-03

Start date

2024-05-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group: In the intervention group, participants will receive 2 tablespoons of barberry extract (Prepared by Sanabel Daru Company) for 12 weeks. The DASH diet will be prescr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 and older Diagnosis of the disease by ultrasound with a standard method ALT >30 IU/L in men and ALT >19 IU/L in women BMI higher than 18.5 and less than 30

Exclusion criteria

Exclusion criteria: Taking corticosteroids Pregnancy and breastfeeding Alcohol consumption (men: ethanol > 140 g per week, women: ethanol > 70 g per week) History of diseases including liver cirrhosis, viral hepatitis, cardiovascular diseases, cancer Medication history including corticosteroids, non-steroidal anti-inflammatory drugs, drugs affecting blood sugar, lipid profile, body weight and liver function. Disease relapse and patient hospitalization Barberry allergy

Design outcomes

Primary

Measure	Time frame
Serum levels of alanine transaminase enzyme. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.	—

Secondary

Measure	Time frame
Severity of hepatic steatosis. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Severity of liver fibrosis. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Severity of liver stiffness. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Controlled Attenuation Parameter (CAP). Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Serum levels of aspartate aminotransferase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.;Serum levels of alkaline phosphatase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.;Serum levels of gammaglutamyltransferase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.	—

Measure

Time frame

Severity of hepatic steatosis. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Severity of liver fibrosis. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Severity of liver stiffness. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Controlled Attenuation Parameter (CAP). Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Fibroscan analysis.;Serum levels of aspartate aminotransferase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.;Serum levels of alkaline phosphatase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.;Serum levels of gammaglutamyltransferase. Timepoint: Before intervention- after intervention (12 weeks after receiving barberry extract or placebo). Method of measurement: Enzymatic method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayyed Saeid Khayyatzadeh

Yazd University of Medical Sciences

khayyatzadeh@yahoo.com+98 35 3820 9100

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026