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A randomized, double-blind, placebo-controlled study of the effects of liver pure tablets on liver function and lipid metabolism in people with alcoholic liver injury

A randomized, double-blind, placebo-controlled study of the effects of liver pure tablets on liver function and lipid metabolism in people with alcoholic liver injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108318
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-08
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic liver damage

Interventions

Liver pure tablet group:Oral liver tablets for 30 days Abstinence from alcohol, 3 times a day, 2 tablets each time
Placebo group:Oral liver pure tablets placebo for 30 days Abstinence from alcohol, 2 tablets 3 times a day

Sponsors

High-tech Hospital of the First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years old (inclusive), gender is not limited; 2.Meet the diagnostic criteria of the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018 Update): Long-term alcohol consumption history (usually more than 5 years), equivalent to ethanol levels >= 40 g/d for men and 20 g/d for women >=; or a history of heavy alcohol consumption within 2 weeks, equivalent to an ethanol amount > 80 g/d. Ethanol content (g) = alcohol consumption (mL) × ethanol content (%) × 0.8; Clinical symptoms are non-specific, may be asymptomatic, and may include right upper quadrant pain, fatigue, nausea, vomiting, loss of appetite, etc.; Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or ?-glutamyltransferase (GGT) are elevated; 3.There is an abnormality in the lipid index (TC, TG, LDL-C, HDL-C); 4.Previous examinations suggested fatty liver and was diagnosed as fatty liver by liver transient elastography; 5.Willing to obey the doctor's intervention plan and cooperate with follow-up, informed consent and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver injury, vascular liver disease, genetic metabolic liver disease, or primary liver cancer; 2.Individuals with serious diseases of important organs such as cardiovascular, lung, liver, and kidney diseases, or patients with diabetes, severe thyroid disease, metabolic diseases, malignant tumors, or severe immune system diseases; 3.Patients who are unable to abstain from alcohol during the study; 4.Known allergy or contraindication to any component of the study drug; 5.Those who have taken other drugs or therapies related to the efficacy of the treatment of this disease within 3 months, those who have lost weight or participated in other interventional clinical experiments; 6.Pregnancy, lactation, and having a birth plan during the trial period; 7.Other conditions that the investigator deems unsuitable for participation in the study;

Design outcomes

Primary

MeasureTime frame
Clinical improvement is effective;

Secondary

MeasureTime frame
Indicators of liver function;Blood lipid indicators;Clinical symptom score;BMI;Liver stiffness and degree of hepatic steatosis;

Countries

China

Contacts

Public ContactZeng Hao

High-tech Hospital of the First Affiliated Hospital of Nanchang University

Zhenhao388@sohu.com+86 138 7062 7755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026