Liver Function Failure
Conditions
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.
Interventions
DRUGTONKA
Administered orally twice a day, 2 tablets each time, for 6 weeks.
DRUGLEGALON
Administered orally three times a day, two tablets each time, for 6 weeks
Sponsors
Nhat Nhat Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Block randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 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 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 |
Other
| Measure | Time frame |
|---|---|
| The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
| The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
| The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
| The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
Countries
Vietnam
Contacts
Primary ContactPhuong Tran, BA
Outcome results
None listed