Subjects with excessive alcohol intake may experience alcohol-induced intoxication discomfort and alcoholic hepatitis.
Conditions
Interventions
Metadoxine group:Orally take one Metadoxine capsule (0.25g) before drinking 100mL of 52% vol Hong ** white liquor.
Artemisiae scopariae Herba water extract (extracellular vesicle-like particles derived from vesicle-like particles derived from Artemisiae scopariae Herba) group) group:10 mL of a solution containing
Sponsors
Guangzhou University of Traditional Chinese Medicine Third Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. ALT/AST: 0.8-1.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) =1×ULN; Child-Pugh score =5 points (only for grade A). 2. Age: 18-60 years old, gender. 3. BMI: 18.5-28 kg/m². 4. History of tolerating single episodes of alcohol consumption =40g ethanol (equivalent to 100ml of 52%vol white spirit); Negative alcohol breath test during screening (BAC=0%). 5. Signed informed consent, committed to abstaining from alcohol during the study period and follow-up.
Exclusion criteria
Exclusion criteria: 1. Liver-related diseases 1) Severe liver disease: Hepatic cirrhosis (imaging or liver stiffness measurement = F4), liver cancer, liver failure, esophageal varices 2) Other liver injuries: Viral hepatitis (HBV/HCV positive), drug-induced liver injury, autoimmune liver disease 3) Complications: Hepatic encephalopathy, ascites, hepatorenal syndrome 2. Systemic diseases 1) Cardiovascular: Uncontrolled hypertension (SBP = 160 mmHg/DBP = 100 mmHg), coronary artery disease, arrhythmia (QTc > 450 ms) 2) Metabolic/endocrine: Diabetes (HbA1c = 7%), hyperthyroidism, hypokalemia (serum K< 3.5 mmol/L) 3) Digestive system: Acute pancreatitis, gastric ulcer bleeding, inflammatory bowel disease 4) Mental/neurological: Epilepsy, alcohol dependence syndrome (DSM-5 diagnosis), major depressive disorder 3. Other factors 1) Use of hepatoprotective drugs (saponins, silibinin, etc.), hangover remedies, or antioxidants (vitamin E = 400 IU/day) within 2 weeks prior to screening; 2) Long-term use of glucocorticoids or immunosuppressants; 3) Pregnant or breastfeeding women (pregnancy test negative for women of childbearing age prior to enrollment); 4) Allergic constitution (allergy to study drug components or alcohol); 5) Participation in other clinical trials within 3 months prior to screening; 6) Difficulty in blood collection (e.g., venous atrophy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood alcohol concentration;blood acetaldehyde concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase;Glutamic-oxaloacetic transaminase;Alkaline phosphatase;Tumor Necrosis Factor Alpha (TNF-a);Gamma-glutamyl transferase;Interleukin-6;Total Bilirubin;hs-CRP;malondialdehyde;Superoxide Dismutase;Glutathione; | — |
Countries
China
Contacts
Public ContactWeiyin Zeng
Guangzhou University of Traditional Chinese Medicine Third Affiliated Hospital
Outcome results
None listed