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

PharmaKing

Status and phase: Completed; Phase 4

Conditions: Chronic Liver Disease

Treatments: Drug: Placebo; Drug: Pennel; Drug: Legalon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02347319

P2010-PN004

Details and patient eligibility

About

Purpose

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

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 3 patient groups, including a placebo group

Pennel

Experimental group

Description:

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

Treatment:

Drug: Pennel

Legalon

Active Comparator group

Description:

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

Treatment:

Drug: Legalon

Placebo

Placebo Comparator group

Description:

This group will treated with Placebo for 12 weeks.

Treatment:

Drug: Placebo