A clinical trial assessing the efficacy and safety of DA-5521 in treating hangovers

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0008927
• Lead Sponsor: Dong-A Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-15
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1) Adult male over the age of 19 and under 50
2) Those who have experienced hangovers after drinking
3) Those who have agreed to participate in the clinical trial before it starts and have signed the Informed Consent Form

Exclusion Criteria

If any of the following exclusion criteria are met, the participant was excluded from the clinical trial :
1) Those who cannot consume more than 100 mL of hard liquor
2) Those currently under treatment for severe cardiovascular, immune system, respiratory, hepatobiliary (liver and gallbladder), renal and urinary system, neurological, musculoskeletal, mental, infectious diseases, or malignant tumors
3) Patients with digestive ulcers or reflux esophagitis based on the screening visit criteria
4) Those with a history of gastrointestinal diseases (e.g., Crohn's disease) that could affect the absorption of the test food or gastrointestinal surgeries (however, simple appendectomy or hernia surgery is excluded)
5) Individuals with alcohol use disorder or alcoholism based on the screening visit criteria
6) Those who have consumed alcohol in the past week to an extent that it may interfere with the test based on the screening visit criteria
7) Those continuously taking drugs believed to affect alcohol metabolism (e.g., Antabuse-class drugs), or drugs with a risk of gastrointestinal bleeding [warfarin, clopidogrel, aspirin, NSAIDs, other antipyretic analgesics, and anti-inflammatory analgesics]
8) Those who have taken medications or health functional foods related to liver function improvement within the past 2 weeks based on the screening visit criteria
9) Those who have taken drugs inducing or inhibiting drug metabolism enzymes (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within the past month (30 days) based on the screening visit criteria
10) Those with AST(GOT) or ALT(GPT) levels more than three times the upper normal limit of the institution
11) Those with Creatinine levels more than twice the upper normal limit of the institution
12) Those with TSH less than 0.1 µIU/mL or greater than 10 µIU/mL
13) Those with fasting blood sugar levels of 126 mg/dL or higher or diabetic patients receiving oral hypoglycemics or insulin
14) Those with uncontrolled hypertension (systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher, measured after 10 minutes of rest during the clinical trial)
15) Those who have participated in another interventional clinical trial (including human application trials) within the past 3 months based on the screening visit criteria or plan to participate in another interventional clinical trial during the duration of this trial
16) Those sensitive or allergic to the ingredients of the test food
17) Those deemed inappropriate for the trial by the tester.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Alcohol in the blood after alcohol consumption;Acetaldehyde in the blood after alcohol consumption

Secondary Outcome Measures

Name	Time	Method
Score for individual hangover symptoms after alcohol consumption.;Time taken to reach a blood and breath alcohol concentration of 0.03% or lower;Breath alcohol concentration