RecruitingNot ApplicableNCT07271576

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

Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

10 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria3

  • Presence of severe comorbidities;
  • Allergy to phycocyanin;
  • Patients with a history of severe mental illness that may affect treatment compliance.

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Interventions

DIETARY_SUPPLEMENTphycocyanin

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).

OTHERMaltodextrin (Placebo)

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


Locations(1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

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NCT07271576


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