Investigating the effect of barberry extract on children with fatty liver disease

Evaluation of the effects of Barberis Vulgaris extract on clinical symptoms, para-clinical factors and immunological responses in pediatric patients with Non-alcoholic fatty liver disease (NAFLD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151028024760N6

Enrollment

Registered

2025-12-26

Start date

2026-04-03

Completion date

Unknown

Last updated

2026-02-02

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) in pediatric patients (children aged 12 to 18 years).. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention group 1: Berberis Vulgaris Extract (Active Intervention). This group will receive a daily dose of 5 ml syrup containing 500 mg of standardized Berberis vulgaris extract for 3 months, alon

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients with Non-alcoholic fatty liver disease Age range of 12 to 18 years Not receiving hepatotoxic drugs Increase in liver enzymes to an amount three times higher than the normal limit. Not suffering from underlying diseases such as advanced kidney disease, heart failure, or uncontrolled diabetes. No history of alcohol use

Exclusion criteria

Exclusion criteria: Change in drug regimen or use of hepatotoxic drugs during the 3-month study period Development of other chronic liver diseases such as viral hepatitis, autoimmune hepatitis, etc. Failure of the patient to attend scheduled appointments for clinical, laboratory, and immunological evaluations.

Design outcomes

Primary

Measure	Time frame
Change in serum alanine aminotransferase (ALT) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum aspartate aminotransferase (AST) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum alkaline phosphatase (ALP) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum gamma-glutamyl transferase (GGT) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum interleukin-1 beta (IL-1ß) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum interleukin-18 (IL-18) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).	—

Measure

Time frame

Change in serum alanine aminotransferase (ALT) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum aspartate aminotransferase (AST) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum alkaline phosphatase (ALP) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum gamma-glutamyl transferase (GGT) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum interleukin-1 beta (IL-1ß) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Change in serum interleukin-18 (IL-18) level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

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Secondary

Measure	Time frame
Change in the expression level of the Interleukin-4 (IL-4) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interleukin-10 (IL-10) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interleukin-17A (IL-17A) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Transforming Growth Factor-beta (TGF-ß) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interferon-gamma (IFN-?) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the PNPLA3 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the SREBP-1 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the SOCS1 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of miR-122. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of miR-155. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.	—

Measure

Time frame

Change in the expression level of the Interleukin-4 (IL-4) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interleukin-10 (IL-10) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interleukin-17A (IL-17A) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Transforming Growth Factor-beta (TGF-ß) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interferon-gamma (IFN-?) gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the PNPLA3 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the SREBP-1 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the SOCS1 gene. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of miR-122. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of miR-155. Timepoint: Before intervention and 3 months after intervention. Method of measurement: SYBR Green-based real-time PCR assay.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojgan Mohammadi

Mashhad University of Medical Sciences

MohammadiMZH@thums.ac.ir+98 51 3800 2376

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026