alcoholic liver disease
Conditions
Interventions
Placebo group:Essential phospholipid + Placebo tablets
Probiotic group:Essential phospholipid + Probiotic tablets
Antialcoholism and liver protection tablets group:Essential phospholipid + Antialcoholism and liver protection tablets
Sponsors
Provincial hospital of Jiangsu Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed alcoholic liver disease were selected, and the diagnosis met the following diagnostic criteria of China's Guidelines for the Prevention and Treatment of alcoholic liver disease (2018 updated version) : (1) There was a long-term history of alcohol consumption (generally more than 5 years), and the equivalent alcohol amount was greater than or equal to 40g/d for men and 20g/d for women; Or a history of heavy drinking within 2 weeks, equivalent to more than 80g/d of ethanol); ? Abnormal or slightly abnormal levels of serum glutamic oxaloacetic transaminase (AST), glutamyl transaminase (ALT), glutamyl transpeptide (GGT), total bilirubin (TBil), prothrombin time (PT), mean red blood cell volume (MCV) and other indexes; Or ? the imaging diagnosis meets the criteria of fatty liver or liver fibrosis, and the serum ALT, AST or GCT levels are abnormal. 2. Study participants aged 18-65 (including 18 and 65 years); 3. No hormones or other drugs affecting systemic immune function have been used within 3 months before the test; 4. Understand the research procedures and content, and be willing to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other liver diseases such as hepatitis B and C; 2. Participated in other drug clinical trials within four weeks; 3. Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 4. Patients with hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) who are not well controlled by single antihypertensive medication; Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: =450 ms in men and =470 ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; 5. Patients with autoimmune liver disease, drug-induced liver disease, toxic hepatitis, liver malignancy, nonalcoholic fatty liver disease, occult hepatitis, and liver disease of unknown cause; 6. Pregnant or lactating women, allergic; 7. Patients who do not follow medical advice, do not use drugs according to regulations, have mental disorders that cannot cooperate with this study, and patients with incomplete data that may affect the efficacy judgment or safety judgment; 8. Patients with concomitant diseases, such as heart, brain, lung, kidney, hematopoietic, immune and other system diseases that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the patient's completion of the study; 9. Other conditions deemed unsuitable for inclusion by the researcher. (including alcohol-dependent people)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AST;ALT;Fecal flora sequencing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ultrasonography of liver; | — |
Countries
China
Contacts
Public ContactGuangxia Liu
Provincial hospital of Jiangsu Province
Outcome results
None listed