Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: phycocyanin, Maltodextrin (Placebo).
- Who it may be relevant to
- Registry conditions: Liver Fibrosis, Liver Cirrhosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis
Overview
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.
Interventions
- Dietary supplement 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). - Other Maltodextrin (Placebo)
This is the placebo control group. The patients will receive the same dosage of maltodextrin for at least 4 weeks.
Primary outcome measures
- Change in Liver Stiffness Measured by Ultrasound Elastography [Time frame: Baseline (Day 0) and Post-treatment (Week 4)]
- Change in Serum Alanine Aminotransferase (ALT) Level [Time frame: Baseline (Day 0) and Post-treatment (Week 4)]
- Change in Serum Aspartate Aminotransferase (AST) Level [Time frame: Baseline (Day 0) and Post-treatment (Week 4)]
Secondary outcome measures (5)
- Gene Expression Changes in Liver Tissue [Time frame: At the time of liver transplantation surgery (if applicable)]
- Change in Serum IL-6 Concentration [Time frame: Baseline (Day 0) and Week 4]
- Change in Serum TNF-α Concentration [Time frame: Baseline (Day 0) and Week 4]
- Gut Microbiome Composition and Diversity [Time frame: Baseline (Day 0) and Week 4]
- Change in Serum Metabolite Concentrations Identified by Mass Spectrometry [Time frame: Baseline (Day 0) and Week 4]
Eligibility criteria
Inclusion criteria
- Adults between the ages of 18 and 75;
- Patients diagnosed with liver fibrosis or cirrhosis;
- Voluntary participation in this study and signing of an informed consent form;
- No acute diseases or significantly worsening symptoms for at least 4 weeks prior to enrollment.
Exclusion criteria
- Presence of severe comorbidities;
- Allergy to phycocyanin;
- Patients with a history of severe mental illness that may affect treatment compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07271576 · 2025-0673