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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Function Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Block randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TONKA

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

Group Type EXPERIMENTAL

TONKA

Intervention Type DRUG

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

LEGALON

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

Group Type ACTIVE_COMPARATOR

LEGALON

Intervention Type DRUG

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

Interventions

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TONKA

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

Intervention Type DRUG

LEGALON

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

Intervention Type DRUG

Eligibility Criteria

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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