Chronic Liver Disease
Conditions
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.
Interventions
Sponsors
PharmaKing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized rate in serum ALT | 12 weeks | The rate of alanine aminotransferase (ALT) normalization |
Secondary
| Measure | Time frame |
|---|---|
| AST | 8, 12 weeks |
| γ-GTP | 8, 12 weeks |
| AST/ALT ratio | 8, 12 weeks |
| ALT | 8, 12 weeks |
| Albumin | 8, 12 weeks |
| Total Bilirubin | 8, 12 weeks |
| The assessment of health-related quality of life | 12 weeks |
| ALP | 8, 12 weeks |
Countries
South Korea
Outcome results
None listed