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Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease

Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04028869
Enrollment
400
Registered
2019-07-23
Start date
2018-03-01
Completion date
2019-03-30
Last updated
2019-07-23

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

Conditions

Autoimmune Liver Disease

Keywords

Autoimmune liver disease, glycyrrhizic acid, liver function

Brief summary

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Detailed description

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Interventions

DRUGGlycyrrhizic acid preparation

To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 1\) Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015); * 2\) no hormones and / or immunosuppressants and other liver protection drugs; * 3\) Sign the written informed consent form.

Exclusion criteria

* 1\) Combine other hepatitis virus (HCV, HDV) infections; * 2\) viral liver disease; * 3\) HIV infection; * 4\) long-term alcohol abuse and / or other liver damage drugs; * 5\) mental illness; * 6\) Evidence of liver tumors (liver cancer or AFP \> 100 ng/ml); * 7\) decompensated cirrhosis; * 8\) Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up; * 9\) There are hormones and / or immunosuppressants and other liver protection drugs.

Design outcomes

Primary

MeasureTime frameDescription
The ratio of sustained biochemical responsesat 96 weeks and 144 weeks after treatmentThe ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease

Secondary

MeasureTime frameDescription
The incidence of decompensated liver cirrhosis and liver cancer and its complicationsat 96 and 144 weeks after treatmentThe incidence of decompensated liver cirrhosis and liver cancer and its complications at 96 and 144 weeks after treatment with glycyrrhizic acid in patients with autoimmune liver disease

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026