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临床试验/NCT02744547
NCT02744547已完成不适用

Effect of Spirulina on Serum Hyaluronic Acid as a Marker for Liver Fibrosis in Beta Thalassemic Children With Hepatitis C

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
serum hyaluronic acid levels

研究概览

简要总结

Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate with histological stages of liver fibrosis in hepatitis C patients, so it has a good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

排除标准

  • liver decompensation child younger than 3 years patients with hepatitis B infection

结局指标

主要结局

serum hyaluronic acid levels

时间窗: 3 months

次要结局

  • liver function tests(3 months)
  • aspartate aminotransferase to platelet ratio index (APRI)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Mohamed Elshanshory

head of pediatric hematology and oncology unit

Tanta University

研究点 (2)

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