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NCT Number: NCT04320199

Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Pusan, Ami-dong, 602-739, South Korea

Location status: Recruiting

Location contact

Sang Yeoup Lee, MD

CONTACT

[email protected]

360-1442 ext. 360

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented Protaetia brevitarsis seulensis powder group

Dietary Supplement

This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

Placebo Group

Dietary Supplement

This group takes placebo for 8 weeks

Primary outcomes

  1. Concentration of Gamma-Glutamyl Transpeptidase

    Time frame: 8 weeks

    Gamma-Glutamyl Transpeptidase

Secondary outcomes

  1. Concentration of Aspartate aminotransferase

    Time frame: 8 weeks

    Aspartate aminotransferase

  2. Concentration of Alanine aminotransferase

    Time frame: 8 weeks

    Alanine aminotransferase

  3. Fatigue Severity Scale

    Time frame: 8 weeks

    Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Yeoup Lee, Professor

CONTACT

[email protected]

360-2860 ext. 055

Ye Le Lee

CONTACT

[email protected]

360-2860 ext. 055

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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