Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis/Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Liver Stiffness Measured by Ultrasound Elastography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Presence of severe comorbidities;
- •Allergy to phycocyanin;
- •Patients with a history of severe mental illness that may affect treatment compliance.
结局指标
主要结局
Change in Liver Stiffness Measured by Ultrasound Elastography
时间窗: 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
时间窗: 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
时间窗: Baseline (Day 0) and Post-treatment (Week 4)
Serum AST (U/L) will be evaluated to determine liver inflammation status and treatment response.
次要结局
- Gene Expression Changes in Liver Tissue(At the time of liver transplantation surgery (if applicable))
- Change in Serum IL-6 Concentration(Baseline (Day 0) and Week 4)
- Change in Serum TNF-α Concentration(Baseline (Day 0) and Week 4)
- Change in Serum Metabolite Concentrations Identified by Mass Spectrometry(Baseline (Day 0) and Week 4)
- Gut Microbiome Composition and Diversity(Baseline (Day 0) and Week 4)