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Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - Alcoholic Liver Diseases

Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - Alcoholic Liver Diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076825
Enrollment
Unknown
Registered
2023-10-20
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Alcoholic liver disease

Interventions

Experimental group with Damp-heat accumulated alcoholic fatty liver:Fermented plant drink of Shanzha and Zhijuzi
Control group with Damp-heat accumulated alcoholic fatty liver:Fermented plant drink of Shanzha and Zhijuzi Placebo
Experimental group with Damp-heat accumulated alcoholic hepatitis:Fermented plant drink of Artichoke and Zhijuz
Control group with Damp-heat accumulated alcoholic hepatitis:Fermented plant drink of Artichoke and Zhijuz Placebo
Experimental group with alcoholic fatty liver of liver depression and qi stagnation type:Jinfo Sugan powder
Control group with alcoholic fatty liver of liver depression and qi stagnation type:Jinfo Sugan powder Placebo
Experimental group with Phlegm-stasis accumulation type alcoholic fatty liver:Plant drink of Shanzha and Kunbu
Control group with Phlegm-stasis accumulation type alcoholic fatty liver:Plant drink of Shanzha and Kunbu Placebo

Sponsors

Affiliated Hospital of Shandong University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria for alcoholic liver disease should meet ? the age of 18-65 years; ? Informed consent and signed the informed consent. In addition, each type of syndrome should meet the following criteria: (1) damp-heat accumulated type and meet the diagnostic classification criteria of alcoholic fatty liver; (2) Mild and moderate liver injury of damp-heat accumulated type and meeting the diagnostic classification criteria of alcoholic hepatitis; (3) Liver depression and qi stagnation type and meet the diagnostic classification criteria of alcoholic fatty liver; (4) Phlegm and blood stasis accumulation type and meet the diagnostic classification criteria of alcoholic fatty liver.

Exclusion criteria

Exclusion criteria: (1) severe underlying diseases such as cardiovascular and cerebrovascular diseases, kidney diseases, blood diseases, endocrine diseases, lung diseases, neuropsychiatric diseases or serious diseases affecting survival, such as tumors or AIDS; (2) infected with viral hepatitis or human immunodeficiency virus (HIV); (3) Patients with non-alcoholic hepatitis; (4) Patients with autoimmune liver disease and hereditary metabolic liver disease; (5) Liver injury caused by drugs or poisoning; (6) Fatty liver disease caused by hepatitis virus infection, drug and toxic liver injury, autoimmune liver disease, etc.; (7) Liver cirrhosis; (8) Have accepted other new drug clinical experimenters within the last 3 months; (9) pregnant or planning to become pregnant and breastfeeding women; (10) People who have been allergic to multiple drugs or allergic constitution; (11) a combination of mental illness, alcoholism and/or psychoactive substance drug abusers and dependent persons; (12) Severe liver injury.

Design outcomes

Primary

MeasureTime frame
Aspartate aminotransferase;Alanine aminotransferase;?-glutamyl transferase;Total bilirubin;Direct bilirubin;Indirect bilirubin;Abdominal color ultrasound;

Countries

China

Contacts

Public ContactSun Jianguang

Affiliated Hospital of Shandong University of TCM

15275319001@163.com+86 152 7531 9001

Outcome results

None listed

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