The effect and safety of extract of pedicel of Hovenia dulcis on alcohol metabilism and hangover improvement in human study

Not Applicable

Active, not recruiting

• Conditions: Not Applicable

• Registration Number: KCT0001626
• Lead Sponsor: Ewha Womans University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

1) The particioants who give informed consent before the start
2) 20~40 years old, healthy male
3) BMI 18-25 kg/m2
4) Men who have a experience of hang over after drinking alcohol
5) Men with ALDH2 heterozygote

Exclusion Criteria

1) Subject who drunk alcohol severely within 7 days prior to the first visit
2) Subject who has alcohol use disorder or alcohol intoxication
3) Subject who consumed the functional food within 4 weeks prior to the first visit
4) Subject who takes drugs such as
: has a effect on alcohol metabolism, have a risk of hematemesis such as aspirin, Nonsteroidal anti-inflammatory drug (NSAID), analgesic
5) Subject with diabetes mellitus, hypertension, renal dysfunction, hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2.5 times the upper limit of normal), pancreatitis, gout, cardiovascular disease, lung disease, gastrointestinal (GI) tract dysfunction, gastrointestinal bleeding, history of GI tract surgery, Neurologic Disorder, Tuberculosis or mental disease
6) hypersensitivity for alcohol or test materials
7) Subject who has participated in another investigational study within 4 weeks prior to the first visit
8) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symtom of hang over;metabolism of alcohol biomarkers;Comparison of time point (endotoxin, Lipopolysaccharide Binding Protein, CD14(cluster of differentiation 14))

Secondary Outcome Measures

Name	Time	Method
Others (endotoxin, Lipopolysaccharide Binding Protein, CD14(cluster of differentiation 14))