NCT02347319

Brief Summary

Purpose \- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

June 11, 2013

Last Update Submit

January 26, 2015

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Normalized rate in serum ALT

    The rate of alanine aminotransferase (ALT) normalization

    12 weeks

Secondary Outcomes (8)

  • ALT

    8, 12 weeks

  • AST

    8, 12 weeks

  • γ-GTP

    8, 12 weeks

  • AST/ALT ratio

    8, 12 weeks

  • ALP

    8, 12 weeks

  • +3 more secondary outcomes

Study Arms (3)

Pennel

EXPERIMENTAL

This group will treated with DDB 25mg/Garlic oil 50mg for 12 weeks.

Drug: Pennel

Legalon

ACTIVE COMPARATOR

This group will treated with Silymarin 140mg for 12 weeks.

Drug: Legalon

Placebo

PLACEBO COMPARATOR

This group will treated with Placebo for 12 weeks.

Drug: Placebo

Interventions

PennelDRUG

Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid

Also known as: DDB/Garlic oil
Pennel
LegalonDRUG

Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid

Also known as: Silymarin
Legalon
PlaceboDRUG

Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid

Also known as: Lactose
Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 20years of age
  • Patients with more 60 ALT in screening period.
  • To evaluate ALT and AST at least three months.
  • Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days
  • Women of childbearing age get her consent for contraception, pregnancy urine test result negative.

You may not qualify if:

  • ALT\>10UNL on screening period.
  • Current treatment on another clinical trial
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The catholic university of korea, Bucheon ST. Mary's Hosipital

Bucheon-si, Gyeonggi-do, 420-717, South Korea

Location

MeSH Terms

Interventions

SilymarinLactose

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

January 27, 2015

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

KR(1)