TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.

Nhat Nhat Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Liver Function Failure

Treatments: Drug: LEGALON; Drug: TONKA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216668

TONKA-V3

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

TONKA

Experimental group

Description:

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

Treatment:

Drug: TONKA

LEGALON

Active Comparator group

Description:

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

Treatment:

Drug: LEGALON