Clinical trial NCT03216668: TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Function Failure
Lead sponsor: Nhat Nhat Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: 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)
timeFrame: 3 weeks
measure: 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)
timeFrame: 6 weeks
measure: The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
timeFrame: 3 weeks
measure: The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
timeFrame: 6 weeks
measure: The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)
timeFrame: 3 weeks
measure: The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)
timeFrame: 6 weeks
measure: The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
timeFrame: 3 weeks
measure: The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)
timeFrame: 6 weeks
measure: The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
timeFrame: 3 weeks
measure: The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
timeFrame: 6 weeks
measure: The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).
timeFrame: 6 weeks
measure: The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).
timeFrame: 6 weeks
Other outcomes:
measure: The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon)
timeFrame: week 6, week 10
measure: The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon)
timeFrame: week 6, week 10
measure: The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon)
timeFrame: week 6, week 10
measure: The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
timeFrame: week 6, week 10
Locations:
city: Hue
country: Vietnam
facility: Hue Central General Hospital
Study officials:
References: