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

Nhat Nhat Pharmaceutical Company140 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Liver Function Failure

Interventions

TONKADRUG

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

LEGALONDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hue Central General Hospital

Huế, Vietnam

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 6 weeks

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 3 weeks

Central Contacts

Phuong Tran, BA

CONTACT

84.72.3817 117 lienhe@nhatnhat.com

Data from ClinicalTrials.gov

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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)

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 6 weeks

The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)

Time frame: 3 weeks

The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)

Time frame: 6 weeks

The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)

Time frame: 3 weeks

The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)

Time frame: 6 weeks

The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)

Time frame: 3 weeks

The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)

Time frame: 6 weeks

The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)

Time frame: 3 weeks

The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)

Time frame: 6 weeks

The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).

Time frame: 6 weeks

The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).

Time frame: 6 weeks