Effects of a fermented powder on liver disease caused by alcohol
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial
NA · Pusan National University Yangsan Hospital · NCT04320199
This study is testing if a special fermented powder can help adults with liver disease caused by alcohol feel better over eight weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital (other) |
| Locations | 1 site (Pusan, Ami-dong) |
| Trial ID | NCT04320199 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Fermented Protaetia brevitarsis seulensis powder on adults suffering from alcohol-induced liver disease over an 8-week period. It is designed as a randomized, double-blind, placebo-controlled trial, where participants will receive either the fermented powder or a placebo daily. The study aims to assess liver function by measuring various metabolic parameters, including gamma-glutamyl transferase and alanine aminotransferase, at the start and after 4 and 8 weeks of treatment. The safety of the compound will also be evaluated throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults with elevated gamma-glutamyl transferase levels due to alcohol-induced liver disease.
Not a fit: Patients with severe liver or renal dysfunction, diabetes, or a history of viral hepatitis or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve liver function in patients with alcohol-induced liver disease.
How similar studies have performed: While previous studies suggest potential benefits of similar fermented products, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pusan, Ami-dong
- Pusan National University Yangsan Hospital — Pusan, Ami-dong, South Korea (RECRUITING)
Study contacts
- Principal investigator: Sang Yeoup Lee, Professor — Pusan National University Yangsan Hospital
- Study coordinator: Sang Yeoup Lee, Professor
- Email: saylee@pnu.edu
- Phone: 360-2860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcoholic Liver Disease