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

NCT ID: NCT07271576

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2027-06-04

Brief 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.

Conditions

Liver Fibrosis; Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phycocyanin Intervention

Group Type: EXPERIMENTAL

phycocyanin

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: PLACEBO_COMPARATOR

Maltodextrin (Placebo)

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaopeng Cai

Role: CONTACT

cxpeng@zju.edu.cn

+86 18768161626

Facility Contacts

Xiaopeng Cai

Role: primary

cxpeng@zju.edu.cn

+86 18768161626

Other Identifiers

2025-0673

Identifier Type: -

Identifier Source: org_study_id