The effect of Robuvit on the healing process of non-alcoholic fatty liver disease

The effect of Robuvit on the healing process of non-alcoholic fatty liver disease: a randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84281116

Enrollment

Registered

2023-11-23

Start date

2024-01-01

Completion date

Unknown

Last updated

2023-12-04

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) Digestive System

Interventions

This double-blind, randomized, placebo-controlled project will study the effect of 12 weeks administration of Robuvit in a dose of 300 mg/day (200 mg in the morning and 100 mg at lunch) on disease sym

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. NAFLD patients aged 20 - 75 years on the same standard treatment during the study period. Standard treatment assumes and guarantees that patients will not take any other drugs 2. Patients willing to sign informed consent 3. Patients willing to take daily Robuvit® / Placebo and provide blood samples.

Exclusion criteria

Exclusion criteria: 1. Patients under 20 or over 75 years of age. 2. Patients enrolled in other study. 3. Patients with an unstable, severe or rapidly progressing form of the disease. 4. Patients with kidney damage, infected with the HIV virus, with other serious diseases of the cardiovascular system, kidneys, gastrointestinal tract, hematopoietic system, with malignant diseases, etc.) 5. Participants who are unable / unwilling to sign an informed consent. 6. Participants who are unable / unwilling to provide samples of biological material as needed

Design outcomes

Primary

Measure	Time frame
1. Effect on the functional parameters of the liver. Total plasma proteins, albumin, prealbumin, ALT, AST, ALP (alkaline phosphatase), LDH, CHE, GMT, IgA, bilirubin (conjugated, non-conjugated), prothrombin, prothrombin time, total transferrin, iron, measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. 2. Effect on the lipid profile and Cyt-2E1 and PON1 activities. Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, TAG), measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. HDL and LDL subfractions measured using electrophoretic Lipoprint system at baseline and after 12 weeks of intervention. Activities of Cyt-2E1 biotransformation enzyme and PON 1 (arylesterase and lactonase) using spectrophotometric method at baseline and after 6 and 12 weeks of intervention. 3. Effect on liver steatosis and fibrosis progression measured using transient elastography at baseline and after 12 weeks of intervention.	—

Measure

Time frame

1. Effect on the functional parameters of the liver. Total plasma proteins, albumin, prealbumin, ALT, AST, ALP (alkaline phosphatase), LDH, CHE, GMT, IgA, bilirubin (conjugated, non-conjugated), prothrombin, prothrombin time, total transferrin, iron, measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. 2. Effect on the lipid profile and Cyt-2E1 and PON1 activities. Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, TAG), measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. HDL and LDL subfractions measured using electrophoretic Lipoprint system at baseline and after 12 weeks of intervention. Activities of Cyt-2E1 biotransformation enzyme and PON 1 (arylesterase and lactonase) using spectrophotometric method at baseline and after 6 and 12 weeks of intervention. 3. Effect on liver steatosis and fibrosis progression measured using transient elastography at baseline and after 12 weeks of intervention.

—

Secondary

Measure	Time frame
1. Changes in basic and specific biochemical parameters (fasting glucose, total plasma proteins, blood count, uric acid, urea, a2-macroglobulin, apolipoprotein A-I,) measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. Hyaluronic acid measured using ELISA at baseline and after 12 weeks of intervention. 2. Changes in glycaemic control markers (insulin, insulin resistance, leptin, adiponectin) measured at certified Laboratory of Clinical Biochemistry at baseline and after 12 weeks of intervention, 3. Changes in the level of free fatty acids in the plasma measured by gas chromatography at baseline and after 6 and 12 weeks of intervention, 4. Changes in the quality of life of patients with NAFLD evaluated by SF-12 questionnaire at baseline and after 6 and 12 weeks of intervention.	—

Measure

Time frame

1. Changes in basic and specific biochemical parameters (fasting glucose, total plasma proteins, blood count, uric acid, urea, a2-macroglobulin, apolipoprotein A-I,) measured at certified Laboratory of Clinical Biochemistry at baseline and after 6 and 12 weeks of intervention. Hyaluronic acid measured using ELISA at baseline and after 12 weeks of intervention. 2. Changes in glycaemic control markers (insulin, insulin resistance, leptin, adiponectin) measured at certified Laboratory of Clinical Biochemistry at baseline and after 12 weeks of intervention, 3. Changes in the level of free fatty acids in the plasma measured by gas chromatography at baseline and after 6 and 12 weeks of intervention, 4. Changes in the quality of life of patients with NAFLD evaluated by SF-12 questionnaire at baseline and after 6 and 12 weeks of intervention.

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Countries

Slovakia

Contacts

Public ContactJana Muchová

jana.muchova@fmed.uniba.sk+42 1290119411

Outcome results

None listed

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