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A randomized, double-blind, placebo-controlled study of Zhige Baogan Jiangzhi decoction on prevention and treatment of alcoholic liver disease

A randomized, double-blind, placebo-controlled study of Zhige Baogan Jiangzhi decoction on prevention and treatment of alcoholic liver disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071160
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-10
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Alcoholic liver disease

Interventions

Treatment group:Liuwei Zhiji Gegen Sangshen oral liquid
Control group:Placebo of the Liuwei Zhiji Gegen Sangshen oral liquid

Sponsors

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who met the western medical diagnostic criteria of ALD, mild ALD, alcoholic fatty liver and mild alcoholic hepatitis without obvious clinical discomfort were selected as study subjects. (1) Mild ALD: the liver biochemical, imaging and histopathological examinations were basically normal or slightly abnormal; (2) Alcoholic fatty liver: imaging diagnosis meets the criteria of fatty liver, and serum ALT, AST or GGT may be slightly abnormal; (3) Mild alcoholic hepatitis: elevated serum ALT, AST or GGT, and may have elevated serum TBIL; Inclusion age criteria Patients between 18-70 years old; those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Liver injury caused by viral infection, metabolic abnormalities, drugs and poisons; 2. Autoimmune liver disease; 3. Liver cancer; 4. Pregnant or lactating women; 5. Pregnancy preparation; 6. Severe heart, liver, kidney and hematopoietic system diseases; 7. Allergic to the drugs used in this study; 8. Redrinkers during treatment; 9. Psychiatric patients can not cooperate; 10. Can not adhere to 3 courses (3 months) of treatment.

Design outcomes

Primary

MeasureTime frame
Liver Elasticity Test;

Secondary

MeasureTime frame
liver function test;Blood lipid testingBlood lipid testing;Body mass index;Liver ultrasound examination;

Countries

China

Contacts

Public ContactZhi Li

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

724232536@qq.com+86 189 8025 1819

Outcome results

None listed

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