Liver cirrhosis
Conditions
Interventions
One cohort:Formula Pinggan 1.6g (i.e. 2 x 0.8 gm tablet) three times daily for 24 weeks
Sponsors
Sundise
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age 18-70; liver cirrhosis of various etiology with MELD score >10; evidence of liver cirrhosis prior to screening documented by evidence of cirrhosis by previous liver biopsy prior to screening, evidence of cirrhosis by ultrasound, CT scan or MRI, or evidence of portal hypertension by endoscopic oesophageal varices, ascites, hypersplenism; Inactive liver disease with ALT < 5x upper limit of normal (<290 IU/l).
Exclusion criteria
Exclusion criteria: Exclusion: history or presence of hepatocellular carcinoma; presence of grade 3 or 4 hepatic encephalopathy; serious medical or psychiatric illnesses; active alcohol or substance abuse; pregnancy, lactation or refusal to use safe contraception methods among female of reproductive age; concomitant use of interferon, anti-viral agents, corticosteroid or immunosuppressive agents; previous use or allergy to Formula Pinggan; serious laboratory abnormality (serum bilirubin > 51 umol/l; serum albumin 1.5x ULN (168 umol/l), hemoglobin < 9.0 g/dl for men and < 8.0 g/dl for women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in mean MELD score among patients on Formula Pinggan; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Child-Pugh score.;2. Proportion of patients with improved MELD and Child-Pugh scores.;3. Cirrhotic complications including bleeding varices, spontaneous bacterial peritonitis, hepatic encephalopathy.;4. Mortality.;5. Safety.; | — |
Countries
China
Contacts
Public ContactDr Henry LY Chan
Outcome results
None listed