To Evaluate the Efficacy of DDB/Garlic Oil in Patients Wi... | NCT02347319

Studies
To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease

NCT02347319

Sponsor

PharmaKing

Status

Completed

Last Update Posted

Jan 27, 2015Estimated

Enrollment

262Actual

Phase

Phase 4

Conditions

Chronic Liver Disease

Interventions

Pennel
Legalon
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 11, 2013

First Submission Date that Met QC Criteria

Jan 26, 2015

First Posted Date

Jan 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2015

Last Update Posted Date

Jan 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose

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

Detailed Description

Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

262Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pennel	Drug	Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid	Pennel	DDB/Garlic oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Normalized rate in serum ALT	The rate of alanine aminotransferase (ALT) normalization	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
ALT		8, 12 weeks
AST		8, 12 weeks
γ-GTP		8, 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The catholic university of korea, Bucheon ST. Mary's Hosipital		Bucheon-si	Gyeonggi-do	420-717	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D012838	Silymarin
D007785	Lactose

Ancestor Terms

ID	Term
D044947	Flavonolignans
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

Browse Leaves

Not provided

Browse Branches

Not provided