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

Phase 3

• Conditions: Liver Function Failure
• Interventions: Drug: LEGALON; Drug: TONKA

• Registration Number: NCT03216668
• Lead Sponsor: Nhat Nhat Pharmaceutical Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-20
• Last Update Posted: 2018-10-23
• Primary Completion: 2019-06-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEGALON	LEGALON	Administered orally three times a day, two tablets each time, for 6 weeks
TONKA	TONKA	Administered orally twice a day, 2 tablets each time, for 6 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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 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 absolute change from Baseline to 3 weeks in Total Bilirubin, 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 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 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)	3 weeks
The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)	3 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
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 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 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 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 absolute change from Baseline to 6 weeks in Total Bilirubin, 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 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 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 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 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 absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)	6 weeks

Trial Locations

Locations (1)

Hue Central General Hospital; 🇻🇳 Hue, Vietnam