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

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Status and phase

Completed
Phase 2

Conditions

Chronic Liver Disease

Treatments

Drug: Placebo
Drug: PENNEL capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01393665
PMK-PENNEL 2

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

88 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
PENNEL capsule
Experimental group
Description:
1cap or 2cap T.I.D
Treatment:
Drug: PENNEL capsule

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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