Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 21, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 4, 2025
June 1, 2025
6 years
March 21, 2020
June 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Concentration of Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase
8 weeks
Secondary Outcomes (3)
Concentration of Aspartate aminotransferase
8 weeks
Concentration of Alanine aminotransferase
8 weeks
Fatigue Severity Scale
8 weeks
Study Arms (2)
Fermented Protaetia brevitarsis seulensis powder group
EXPERIMENTALThis group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 8 weeks
Interventions
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
Eligibility Criteria
You may qualify if:
- Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Pusan, Ami-dong, 602-739, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee, Professor
Pusan National University Yangsan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 21, 2020
First Posted
March 24, 2020
Study Start
January 1, 2020
Primary Completion
December 30, 2025
Study Completion
December 31, 2025
Last Updated
June 4, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share