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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

1997-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01393678

Chronic Liver Disease

COMPLETED PHASE3

To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease

NCT02347319

Chronic Liver Disease

COMPLETED PHASE4

Carnitine and Liver Mitochondria Fatty Acid Processing

NCT03193125

Diabetes Mellitus, Type 2 Insulin Resistance Obesity

COMPLETED NA

A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).

NCT07005752

Cholesterol Cholelithiasis

RECRUITING PHASE4

Phase I Trial of Silymarin for Chronic Liver Diseases

NCT00389376

Hepatitis C Non-Alcoholic Fatty Liver Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PENNEL capsule

1cap or 2cap T.I.D

Group Type EXPERIMENTAL

PENNEL capsule

Intervention Type DRUG

hard capsule DDB 25mg \& GO 50mg in cap .......... 1 capsule

1 or 2 capsule, T.I.D

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PENNEL capsule

hard capsule DDB 25mg \& GO 50mg in cap .......... 1 capsule

1 or 2 capsule, T.I.D

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No