Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease

Chronic Liver Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393678
• Other study ID #: PMK-PENNEL 3
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2011
• Last updated: July 12, 2011
• Start date: November 1997
• Est. completion date: May 1998

Study information

• Verified date: July 2011
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 1998
• Est. primary completion date: March 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with chronic hepatitis by biopsy

• Patients over 20, under 65 years of age.

• Patients with abnormal transaminase value.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Drug:
• NISSEL
Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap
• PENNEL
Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul, Seongdong-gu,

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALT(Alanine Aminotransferase)	To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No
Secondary	AST (Aspartate Aminotransferase)	To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 10 weeks(Change from Baseline in Aspartate Aminotransferase at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No
Secondary	g-GT (?-glutamyl transpeptidase)	To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 10 weeks (Change from Baseline in ?-glutamyl transpeptidase at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No
Secondary	Total bilirubin	To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 10 weeks (Change from Baseline in Total bilirubin at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No
Secondary	PLT (Platelet)	To evaluate the efficacy of the PENNEL capsule on change PLT from baseline to 10 weeks (Change from Baseline in Platelet count at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No
Secondary	Total cholesterol	To evaluate the efficacy of the Oltipraz on change Total cholesterol from baseline to 10 weeks (Change from Baseline in Total cholesterol at 10 weeks); The measurements were conducted four times, including ? before administration, ? the 4th week of administration, ? the 8th week of administration ? the 10th week of administration	10 weeks	No