The effect of branched-chain amino acid granules to innate immunity in decompensated cirrhosis, A randomized controlled trial
Phase 2
- Conditions
- Decompensated cirrhosis,Child-Pugh B,C with documented ascitesand MELD score < 20Amino Acids,Branched-ChainImmunity,InnateLiver Cirrhosis
- Registration Number
- TCTR20190830005
- Lead Sponsor
- Faculty of Medicine, Prince of Songkla University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Age between 18 to 70 years old.
- Diagnosed with cirrhosis either by imaging or histopathology
- Child-Pugh score ≥ 7 points
- History or currently documented ascites by imaging
- Agree to sign inform consent
Exclusion Criteria
- Previous hospitalization due to infection within 3 months
- Any active malignancies
- life expectancy < 9 months
- Stop alcohol drinking < 6 months
- On steroid or Immunosuppressive drugs
- Uncontrolled diabetes mellitus defined by HbA1c ≥ 8 %
- HIV infection
- eGFR < 30 ml/min/1.73m2
- History of taking branched-chain amino acid
- Pregnancy or lactation
- MELD score ≥ 20 points
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the efficacy of branched-chain amino acid granules to restore innate immunity in term of phagocytosi 6 months Phagocytosis function percentage determine by flow cytometry after taking BCAA granules for 6 months
- Secondary Outcome Measures
Name Time Method The clinical outcomes of branched-chain amino acid granules in infection incidence and 6 months Infection incidence and hospitalization due to infection during investigation period.,The Durable effect to phagocytosis of BCAA granules after stop treatment for 3 months 9 months Phagocytosis capacity percentage determine by flow cytometry after stop taking BCAA granules