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Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo

NCT05144217 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-14

No results posted yet for this study

Summary

In this clinical study silymarin will be administered in different dosages and compared to placebo in order to address if the liver protecting features of silymarin, measured by changes of liver enzyme concentration, can be improved in patients with drug-induced elevated liver enzymes or drug-induced hepatocellular liver injury with higher systemic bioavailabilities due to administration of higher oral dosages or administration of higher administration frequency over a 35-day treatment period.

Conditions

  • Drug-induced Liver Injury

Interventions

DRUG

Placebo

1 capsule per day of placebo

DRUG

2x 140 mg per day

2 capsule per day of silimarit

DRUG

3x 280 mg per day

3 capsule per day of silimarit

DRUG

1x 1120 mg

8 capsule per day of silimarit

Sponsors & Collaborators

  • Bionorica SE

    collaborator INDUSTRY

  • Prof. Dr. Frank Behrens

    lead OTHER

Principal Investigators

  • Stephan Schaefer, MD · Fraunhofer ITMP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-12-12
Completion
2024-12-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144217 on ClinicalTrials.gov