Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis

Condition(s) studied

Investigational drug(s) / intervention(s)

phycocyanin: Oral phycocyanin formulation treatment, 1.5g/day, for at least 4 weeks (The phycocyanin was provided free of charge by Inner Mongolia Zaihui Shou Bio-engineering Co., Ltd., with company production license number SC12215062400192, executive standard GB 1886.309-2020, food-grade specifications, and batch number E4020250324. All samples used in the clinical study are from the same batch, packaged in opaque aluminum composite bags, 1.5g/bag, and stored frozen).

Maltodextrin (Placebo): This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.

Study summary

This clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are:

* Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage?
* Can phycocyanin improve liver stiffness as measured by ultrasound?

Researchers will compare the phycocyanin intervention group with a control group that receives a placebo (a similar-looking maltodextrin supplement without active ingredients) to explore if phycocyanin is more effective in treating liver fibrosis/cirrhosis.

Participants will:

* Take one sachet of either phycocyanin or placebo daily for at least 4 weeks.
* Attend regular clinic appointments (typically every 2-3 months) for routine monitoring of your liver condition, which will include blood and urine tests.
* Provide blood and stool samples once before the treatment and once after the 4-week treatment period.
* Undergo an ultrasound evaluation of liver stiffness.

The study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.

Eligibility

Primary outcome measure(s)

• Change in Liver Stiffness Measured by Ultrasound Elastography — Baseline (Day 0) and Post-treatment (Week 4)
  Liver stiffness (kPa) will be quantified using ultrasound elastography to assess fibrosis severity and treatment-related changes.
• Change in Serum Alanine Aminotransferase (ALT) Level — Baseline (Day 0) and Post-treatment (Week 4)
  Serum ALT (U/L) will be measured using standard clinical chemistry methods to assess improvement in liver injury following phycocyanin treatment.
• Change in Serum Aspartate Aminotransferase (AST) Level — Baseline (Day 0) and Post-treatment (Week 4)
  Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response.

Trial sites (1)