NCT03216668

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

July 9, 2017

Last Update Submit

October 20, 2018

Conditions

Liver Function Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

  • 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

  • +21 more secondary outcomes

Other Outcomes (4)

  • The absolute change after treatment discontinuation from week 6 to week 10 in ALT , 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 GGT , compared between Tonka and Silymarin (Legalon)

    week 6, week 10

  • +1 more other outcomes

Study Arms (2)

TONKA

EXPERIMENTAL

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

Drug: TONKA

LEGALON

ACTIVE COMPARATOR

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

Drug: LEGALON

Interventions

TONKADRUG

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

TONKA
LEGALONDRUG

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

LEGALON

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hepatitis B or C.
  • Pregnant or Lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hue Central General Hospital

Huế, Vietnam

RECRUITING

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Phuong Tran, BA

CONTACT

84.72.3817 117lienhe@nhatnhat.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Block randomization
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 13, 2017

Study Start

June 15, 2017

Primary Completion

June 30, 2019

Study Completion

September 30, 2019

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

VN(1)