Effects of a fermented powder on liver disease caused by alcohol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.