Patient with decompensated cirrrhosis Decompensated cirrhosis
Conditions
Interventions
Silymarin 840 mg/day for 12 weeks
Both groups received tablets that were identical in shape, appearance, taste, smell, and color. The prescribed dosage was 2 tablets after each meal (breakfast, lunch,
Active Comparator Drug,Placebo Comparator Drug
Silymarin,Placebo
Sponsors
The Gastroenterological Association of Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The participants aged 20-80 who have received information about the research project 2. The participant have been diagnosed decompensated cirrhosis including at least one complication such as ascites, a history of variceal bleeding, history of overt hepatic encephalopathy or jaundice
Exclusion criteria
Exclusion criteria: 1. Participants who are currently or have previously taken silymarin in the past 6 months. 2. Participants diagnosed with advanced liver cancer (hepatocellular carcinoma BCLC stage C or D) 3. Participants with other types of advanced malignancy. 4. Participants with active gastrointestinal bleeding within the past 2 weeks. 5. Participants with persistent hepatic encephalopathy grade III-IV. 6. Participants with unstable circulation or in a state of shock. 7. Participants who are unable to read and write the Thai version of the assessment form by themselves. 8. Participants with a history of allergic reaction to silymarin. 9. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| severity of cirrhosis at 12 weeks Child Turcotte Pugh score | — |
Secondary
| Measure | Time frame |
|---|---|
| Prognosis at 12 weeks MELD score (calculated using a mathematical formula based on four laboratory values: Bilirubin, Creatinine, Serum sodium and INR) , ALBI score (calculated using formula include albumin and bilirubin),Liver surrogate markers at 12 weeks AST, ALT, albumin, Bilirubin, INR,Quality of life at 12 weeks Patient reported outcome using THAI-WHOQOL-BREF,Admission due to cirrhotic complications within 12 weeks Incidence of admission including : Variceal bleeding, overt hepatic encephalopathy, Spontaneous bacterial peritonitis | — |
Countries
Thailand
Contacts
Public ContactApirat Angsubhakorn
Phramongkutklao hospital
Outcome results
None listed