About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Presence of severe comorbidities;
Allergy to phycocyanin;
Patients with a history of severe mental illness that may affect treatment compliance.
Trial design
Treatments tested in this trial
- phycocyanin
- Maltodextrin (Placebo)
Treatment groups
Locations
1Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor