Chronic Liver Disease
Conditions
Brief summary
The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.
Interventions
DRUGPENNEL capsule
hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D
DRUGPlacebo
Placebo
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic liver disease. * Patients over 20, under 65 years of age. * Patients with abnormal transaminase levels.
Exclusion criteria
* Pregnant and lactating women. * Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites. * Diabetes, thyroid dysfunction, fatty liver, liver cancer patients. * Toxic hepatitis, alcoholic hepatitis. * Total bilirubin value more than 3.0 mg/dl. * Albumin value less than 3.0 g/dl. * Patients who participating in other study about drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALT (Alanine Aminotransferase) | 6 week | To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST (Aspartate Aminotransferase) | 6 weeks | To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration. |
| g-GT (γ-glutamyl transpeptidase) | 6 weeks | To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration. |
| Total bilirubin | 6 weeks | To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks) The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration. |
Countries
South Korea
Outcome results
None listed