Trial | NCT03216668  Report issue

Title

TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
A Randomized, Active-Control, Open Label, Phase IIIb Study to Evaluate the Safety and Efficacy of TONKA Compared With Silymarin (Legalon) for Lowering Hepatic Enzymes in Liver Function Disorder Patients With Moderate to High Elevated Liver

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    140
The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.
Study Started
Jun 15
2017
Primary Completion
Jun 30
2019
Anticipated
Study Completion
Sep 30
2019
Anticipated
Last Update
Oct 23
2018

Drug TONKA

Administered orally twice a day, 2 tablets each time, for 6 weeks.

Drug LEGALON

Administered orally three times a day, two tablets each time, for 6 weeks

TONKA Experimental

Administered orally twice a day, 2 tablets each time, for 6 weeks

LEGALON Active Comparator

Administered orally three times a day, two tablets each time, for 6 weeks

Criteria 

Inclusion Criteria:

Male and Female more than 18 year old.
Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals.
ALT at baseline is in between 150 U/L to 400 U/L
Sign the informed consent form

Exclusion Criteria:

Hepatitis B or C.
Pregnant or Lactating women
No Results Posted