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

Study Overview
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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.

Official Title
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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

Conditions
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Liver Function Failure

Intervention / Treatment
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* Drug: TONKA
* Drug: LEGALON


Participation Criteria
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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 Exclusion Criteria: Hepatitis B or C. Pregnant or Lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TONKA<br>Administered orally twice a day, 2 tablets each time, for 6 weeks | Drug: TONKA<br>* Administered orally twice a day, 2 tablets each time, for 6 weeks.<br>|
| Active Comparator: LEGALON<br>Administered orally three times a day, two tablets each time, for 6 weeks | Drug: LEGALON<br>* Administered orally three times a day, two tablets each time, for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) |  | 3 weeks | 
| The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) |  | 6 weeks | 
| The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon). |  | 6 weeks | 
| The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon). |  | 6 weeks |