Liver cirrhosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Patients with liver cirrhosis under treatment. -Treatment has not been changed within the previous one month, and it is anticipated that the treatment will not be changed within the next one month. -Patients with T-bil < 5mg/dl and serum Alb <= 3.5g/dl.
Exclusion criteria
Exclusion criteria: -Patients with malignant diseases -patients with hepatic coma -Patients with serum Cr >= 2mg/dl -Patients with HIV infection -Patients with autoimmune diseases -Patients who had bleeding from esophageal or gastric varices within the previous 3 months -Patients with severe organ dysfunction -Patients infected with unknown microbe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; Evaluation of adverse events of clinical symptoms and data | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; Subjective symptoms; general fatigue, itching, abdominal fullness, cramp in the legs Objective signs; hepatic coma, ascites, edema, bleeding tendency Laboratory data; AST, ALT, T-Bil, PT, Plt, Alb, P-III-P, Type IV collagen 7S, hyaluronic acid | — |
Countries
Japan
Contacts
Shin-yurigaoka General Hospital Department of Gastroenterology