Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease

February 1, 2023 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital

Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.

Study Overview

Detailed Description

Previous studies have indicated that Fermented Protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. The Investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 4,000 mg of Fermented Protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sang Yeoup Lee, Professor
  • Phone Number: 055 360-2860
  • Email: saylee@pnu.edu

Study Contact Backup

Study Locations

    • Ami-dong
      • Pusan, Ami-dong, Korea, Republic of, 602-739
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit

Exclusion Criteria:

  • Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
  • Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
  • History of viral hepatitis or cancer
  • Uncontrolled hypertension
  • History of serious cardiac disease such as angina or myocardial infarction
  • History of gastrectomy
  • History of medication for psychiatric disease
  • Administration of oriental medicine including herbs within the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fermented Protaetia brevitarsis seulensis powder group
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
PLACEBO_COMPARATOR: Placebo group
This group takes placebo for 8 weeks
This group takes placebo for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Gamma-Glutamyl Transpeptidase
Time Frame: 8 weeks
Gamma-Glutamyl Transpeptidase
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Aspartate aminotransferase
Time Frame: 8 weeks
Aspartate aminotransferase
8 weeks
Concentration of Alanine aminotransferase
Time Frame: 8 weeks
Alanine aminotransferase
8 weeks
Fatigue Severity Scale
Time Frame: 8 weeks
Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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