Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
Primary Purpose
Alcoholic Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fermented Protaetia brevitarsis seulensis powder group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Liver Disease
Eligibility Criteria
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
Sites / Locations
- Pusan National University Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fermented Protaetia brevitarsis seulensis powder group
Placebo group
Arm Description
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
This group takes placebo for 8 weeks
Outcomes
Primary Outcome Measures
Concentration of Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase
Secondary Outcome Measures
Concentration of Aspartate aminotransferase
Aspartate aminotransferase
Concentration of Alanine aminotransferase
Alanine aminotransferase
Fatigue Severity Scale
Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.
Full Information
NCT ID
NCT04320199
First Posted
March 21, 2020
Last Updated
February 1, 2023
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04320199
Brief Title
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
Official Title
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fermented Protaetia brevitarsis seulensis powder group
Arm Type
Experimental
Arm Description
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented Protaetia brevitarsis seulensis powder group
Intervention Description
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
This group takes placebo for 8 weeks
Primary Outcome Measure Information:
Title
Concentration of Gamma-Glutamyl Transpeptidase
Description
Gamma-Glutamyl Transpeptidase
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Concentration of Aspartate aminotransferase
Description
Aspartate aminotransferase
Time Frame
8 weeks
Title
Concentration of Alanine aminotransferase
Description
Alanine aminotransferase
Time Frame
8 weeks
Title
Fatigue Severity Scale
Description
Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Yeoup Lee, Professor
Phone
360-2860
Ext
055
Email
saylee@pnu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Le Lee
Phone
360-2860
Ext
055
Email
yeri1230@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, Professor
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
State/Province
Ami-dong
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Phone
360-1442
Ext
360
Email
saylee@pnu.edu
12. IPD Sharing Statement
Learn more about this trial
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
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