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

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Alcoholic Liver Disease

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group

Study type: Interventional

Funder types: Other

Identifiers

NCT04320199

02-2018-025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups, including a placebo group

Fermented Protaetia brevitarsis seulensis powder group

Experimental group

Description:

This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

Treatment:

Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 8 weeks

Treatment:

Dietary Supplement: Placebo group