drugset / Trial / NCT05144217

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

NCT05144217

Phase 2/3 Completed 19 enrolled Prof. Dr. Frank Behrens Bionorica SE · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 140 mg Oral
Subject Silymarin Traditional medicine (herbal / TCM) 280 mg Oral
Subject Silymarin Traditional medicine (herbal / TCM) 1120 mg Oral