- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320199
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
Status
Recruiting
Conditions
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
- Name: Ye Le Lee
- Phone Number: 055 360-2860
- Email: yeri1230@gmail.com
Study Locations
-
-
Ami-dong
-
Pusan, Ami-dong, Korea, Republic of, 602-739
- Recruiting
- Pusan National University Yangsan Hospital
-
Contact:
- Sang Yeoup Lee, MD
- Phone Number: 360 360-1442
- Email: saylee@pnu.edu
-
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-2018-025
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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