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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01393678
Other study ID # PMK-PENNEL 3
Secondary ID
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


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
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